Latest news with #AAAAI
Yahoo
4 days ago
- Health
- Yahoo
Midea air conditioner recall sparks concern: How to clean mold from your AC safely
Midea is recalling about 1.7 million of the company's U and U+ Window Air Conditioners sold in the U.S. and Canada due to mold exposure concerns, according to a notice shared by the U.S. Consumer Product Safety Commission (CPSC). The affected units were distributed under the popular brand names Midea, Comfort Aire, Danby, Frigidaire, Insignia, Keystone, LBG Products, Mr. Cool, Perfect Aire and Sea Breeze. Water in the recalled air conditioners may pool inside the units and have difficulty draining quickly enough, increasing the risk of mold growth. The company's issued notice states that mold exposure can raise the risk of developing respiratory issues or infections for some users. While this particular recall is focused on select Midea products, mold in air conditioners is a common issue all AC owners should be aware of, Omero Flores, CEO of American AC & Heating, a family-operated HVAC company in Harlingen, Texas, tells Yahoo Life. It's easy to view an air conditioner as a set-it-and-forget-it appliance, but these workhorse machines require regular cleanings to lower the risk of mold buildup. But if you're like most people, you probably don't know how to clean mold from your air conditioner (or how to identify if it needs cleaning in the first place). With that in mind, here's how to check and clean your unit and how to prevent AC mold in your home in the first place. There are a few reasons why mold can grow in air conditioners. For starters, "mold is present almost everywhere," Jamie Alan, an associate professor of pharmacology and toxicology at Michigan State University, tells Yahoo Life. But air conditioners in particular create a mold-friendly environment that allow spores to thrive. "Mold is a common issue in AC units because the cooling process naturally creates moisture," Flores says. "When warm air passes over the evaporator coils, condensation forms." If the moisture doesn't drain properly from your AC — which is what happened with the Midea recall — or if the system stays humid due to poor ventilation or infrequent use, it creates an ideal environment for mold to grow, Flores says. There are a few things that can happen with a moldy air conditioner. "Mold will reduce efficiency and can also circulate spores throughout the home, which can cause health issues like allergies or respiratory irritation," Flores says. According to the American Academy of Allergy Asthma & Immunology (AAAAI), mold and mold spores are incredibly common — you're going to breathe some of them in from the air around you. That said, some people are allergic to mold — their immune systems are overly sensitive to specific types of spores, which can lead to more significant reactions from exposure. Common reactions include sneezing, watery eyes, runny nose and nasal congestion. While there are hundreds of types of molds, the AAAAI notes that the most common ones that cause allergic reactions are Alternaria, Aspergillus, Cladosporium and Penicillium. As to what may happen if mold starts growing inside your AC, Alan says that really depends on the type of mold, as well as how your immune system typically responds to such spores. For instance, people who are immunocompromised or who have underlying respiratory issues are more prone to experience symptoms or health complications from mold exposure. Additionally, aerosolization of mold is a bigger potential issue than mold growing on a random surface, especially for people who are prone to mold issues, Alan says. If you're chronically exposed to mold by something like your AC blowing spores around, you could develop chronic allergy symptoms or other health concerns. "Patients could have lung infections, which could look like a fever, cough and trouble breathing," Alan says. Something else to consider: Certain types of molds, like black mold, can release toxins into the air that can make you sick, even if you don't have a mold allergy. "With things like black mold, there are more symptoms that patients may experience like fatigue, mood changes and brain fog," says Alan. There is also a specific immune reaction to mold spores called hypersensitivity pneumonitis where your lungs become inflamed due to mold exposure. "It leads to a flu-like illness with fever and fatigue, in addition to respiratory symptoms," says Dr. Robert Laumbach, associate professor in the Department of Environmental and Occupational Health and Justice at the Rutgers School of Public Health. "Over time, this could lead to permanent lung damage, so we want to try to catch [it] early." A key sign that mold in your home may be making you sick is if you find that you're having asthma- or allergy-like symptoms in your home that seem to get better after you leave for the day. "Symptoms usually occur with exposure and then may resolve within hours," says Laumbach. (However, he says that it can take longer for symptoms to clear up for some people, so this isn't always a given.) Still, all of this doesn't mean you should panic if you happen to find mold in your AC — especially if you otherwise feel fine. "Not every type of mold causes health issues for humans," Alan points out. There are a few warning signs to look out for. "One of the most noticeable signs is a musty or earthy smell when the system kicks on," Flores says. "It is usually the strongest near vents." You may even spot mold on the vents or around the evaporator coils and drip pan, Flores says. "Unexplained moisture buildup around the unit or damp, stale air could also be red flags," he adds. But you may simply be tipped off to the presence of mold in your AC by how you feel when the AC starts running — pay attention for any telltale allergy symptoms mentioned earlier, like sneezing, a runny nose or coughing. While it's never a bad idea to call in the experts if cleaning your AC seems like an ordeal, in most cases, it's possible to tackle basic cleaning yourself. Flores offers these simple steps. Flores recommends protecting yourself first. That means wearing gloves, a face mask and goggles. "Disturbing mold can release spores," he says. Failing to protect yourself can increase the likelihood of experiencing allergy symptoms or irritation. While basic cleaning is fairly straightforward, it's important to familiarize yourself with your unit and to determine whether the company has specific suggestions for ongoing maintenance. You don't want to be poking around with the electricity still running. Removing these components allows you to clean in and around them more effectively, identifying any areas where mold may be growing. "Small amounts of mold in accessible areas like vent covers or drip pans can sometimes be cleaned with a mixture of water and a mild detergent or a diluted bleach solution," Flores says. But as you remove these parts, "be careful not to damage components," he warns. (This is where consulting the owner's manual may come in handy!) Giving your AC a chance to fully dry before turning it back on will reduce the chances for mold growth to return. If you suspect that mold is in deeper areas of your air conditioner, like the coils or blower motor, Flores says it's best to use professional-grade equipment and antimicrobials. "That's where trained HVAC pros come in, as we can safely clean and sanitize all affected areas without spreading the mold further," he says. Getting rid of mold from your AC unit is helpful, but it can come back again if you're not careful. As always, it's best to read the instruction manual for your unit and follow regular maintenance, as recommended. "Proper routine maintenance can address most of these issues before they become a problem for the home," Sean Goddard, product manager of indoor air quality and coils at HVAC company Trane Technologies, tells Yahoo Life. Beyond that, Goddard says it can be helpful to keep tabs on your indoor humidity. "Indoor humidity should be kept between 30% to 50% for comfort and to prevent mold," he says. "Mold tends to grow when indoor humidity is higher than this range." If humidity is a big issue in your home, Goddard suggests investing in a dehumidifier to try to help lower those levels. You may even want to consider using UV light, Goddard says. "UVC light installed over your coil and drain pan can prevent microbial growth and mold," he says. Laumbach suggests wiping down the inside and outside of your air conditioner regularly to remove dust, and to regularly clean and change your filter. "Dust can be enough food for mold to grow," he says. "You want to keep those coils and the filter clean." You may even want to consider using an additional air purifier with a HEPA filter, or seeing if your AC unit can use a HEPA filter to tamp down on mold spores circulating in your air, Tony Abate, a certified mold inspector and vice president and chief technology officer at AtmosAir Solutions, tells Yahoo Life. (Check out our favorite air purifiers here.) The Environmental Protection Agency (EPA) also recommends keeping your air conditioning drip pans clean and the drain lines unobstructed and flowing properly. Again, mold can be an issue in any air conditioner — not just the models recalled by Midea. Mold exposure can raise the risk of a range of health issues, from allergy symptoms to full-blown infections, making it important to stay on top of the spores in your home. Doing routine air conditioner maintenance and cleanings will help to lower the risk of mold issues happening in the first place. Omero Flores, CEO of American AC & Heating in Harlingen, Texas Jamie Alan, RPH, PharmD, PhD, associate professor of pharmacology and toxicology at Michigan State University Robert Laumbach, MD, MPH, CIH, associate professor in the Department of Environmental and Occupational Health and Justice at the Rutgers School of Public Health Sean Goddard, product manager of indoor air quality and coils at Trane Technologies Tony Abate, a certified mold inspector and chief technology officer at AtmosAir Solutions Our health content is for informational purposes only and is not intended as professional medical advice. Consult a medical professional on questions about your health.
Yahoo
12-05-2025
- Business
- Yahoo
Jasper Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
REDWOOD CITY, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting KIT to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today reported results for the fiscal quarter ended March 31, 2025 and provided a corporate update. 'During the first quarter of 2025 we made great progress advancing briquilimab toward important data readouts later this year from all three of our clinical programs in mast cell diseases,' said Ronald Martell, President and Chief Executive Officer of Jasper. 'Updated data from the BEACON study in CSU presented at the AAAAI annual meeting continued to demonstrate the potential of briquilimab to deliver differentiated onset of action, depth of response, and tolerability. We look forward to our mid-year data update in the first half of Q3 2025, which will include additional CSU patients treated in the BEACON study and in the open-label extension study. These data will inform final dose selection for our planned Phase 2b study, expected to commence in the fourth quarter of 2025. We also remain on track to present additional data from the SPOTLIGHT study in CIndU in the second quarter as well as initial data from the ETESIAN study in asthma in the second half of 2025.' Highlights for First Quarter 2025 and Recent Weeks Continued to enroll patients in the BEACON Phase 1b/2a study of subcutaneous briquilimab in CSU. Jasper plans to report data from additional patients enrolled in the BEACON study, as well as from CSU patients enrolled in the open-label extension (OLE) study, in the first half of Q3 2025. Completed enrollment in the third and final cohort (180mg) of the SPOTLIGHT Phase 1b/2a study of subcutaneous briquilimab in cold urticaria (ColdU) or symptomatic dermographism (SD), the two most prevalent sub types of CIndU. Jasper plans to report data from additional patients enrolled in the study at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in June 2025. Presented updated data from the BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU at the annual meetings of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American Academy of Dermatology (AAD). The update presented was based on a data-cut date of January 31, 2025, and includes approximately one month of additional dosing and follow-up from the 49 participants featured in Jasper's previous data disclosure in January 2025. Briquilimab continued to be well tolerated and demonstrate a favorable safety profile in the study, with no additional adverse events (AEs) potentially related to KIT blockade observed. Data collected in the study to-date support advancing briquilimab into a registrational program in CSU, beginning with a planned Phase 2b operationally-adaptive study expected to commence in the second half of 2025. Final dose selection for the Phase 2b study will be further informed by additional clinical data from patients administered doses of 180mg and higher, expected to be reported mid-year 2025. Open-label Extension Study – Study commenced in CSU that will roll over patients from the BEACON and SPOTLIGHT studies upon completion of their initial follow-up period. The ETESIAN Phase 1b/2a allergen challenge study evaluating a single administration of subcutaneous briquilimab in allergic asthma continues to enroll patients. Jasper expects to report initial data from ETESIAN in the second half of 2025. First Quarter Fiscal 2025 Financial Results Cash and cash equivalents as of March 31, 2025, totaled $48.8 million. Research and development expenses for the three months ended March 31, 2025, was $16.2 million. General and administrative expenses for the three months ended March 31, 2025, was $5.6 million. Jasper reported a net loss of $21.2 million, or basic and diluted net loss per share attributable to common stockholders of $1.41, for the three months ended March 31, 2025. About Jasper Jasper is a clinical-stage biotechnology company focused on developing briquilimab as a therapeutic for chronic mast cell diseases. Briquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor KIT, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria and asthma. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU, CIndU or asthma. Briquilimab has a demonstrated efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU and CIndU. For more information, please visit us at Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab's potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma and its potential to deliver differentiated onset of action, depth of response and tolerability; Jasper's expected timing for presenting study results for additional CSU patients treated in the BEACON study and in the open-label extension study; its expected timing for presenting additional data from the SPOTLIGHT study and initial data from the ETESIAN study; and its expected timing for commencing its planned Phase 2b operationally adaptive study. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that prior test, study and trial results may not be replicated in continuing or future studies and trials; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper's product candidates may not be beneficial to patients or successfully commercialized; patients' willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper's business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper's business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts:Alex Gray (investors)Jasper Therapeutics650-549-1454 agray@ Joyce Allaire (investors)LifeSci Advisors617-435-6602jallaire@ Lauren Walker (media)Real Chemistry646-564-2156lbarbiero@ ---tables to follow---JASPER THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, 2025 2024 Operating expenses Research and development(1) $ 16,157 $ 10,298 General and administrative(1) 5,645 4,774 Total operating expenses 21,802 15,072 Loss from operations (21,802 ) (15,072 ) Interest income 624 1,386 Other expense, net (63 ) (42 ) Total other income, net 561 1,344 Net loss and comprehensive loss $ (21,241 ) $ (13,728 ) Net loss per share attributable to common stockholders, basic and diluted $ (1.41 ) $ (1.03 ) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,022,122 13,334,900 (1) Amounts include non-cash stock based compensation expense as follows (in thousands): Three Months Ended March 31, 2025 2024 Research and development $ 1,240 $ 820 General and administrative 571 349 Total $ 1,811 $ 1,169 JASPER THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) March 31, December 31, Assets 2025 2024 Current assets: Cash and cash equivalents $ 48,799 $ 71,637 Prepaid expenses and other current assets 4,375 4,174 Total current assets 53,174 75,811 Property and equipment, net 1,599 1,875 Operating lease right-of-use assets 1,875 976 Restricted cash 417 417 Other non-current assets 532 820 Total assets $ 57,597 $ 79,899 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,995 $ 4,027 Current portion of operating lease liabilities 1,835 1,089 Accrued expenses and other current liabilities 7,504 10,121 Total current liabilities 12,334 15,237 Non-current portion of operating lease liabilities 755 724 Other non-current liabilities 2,264 2,264 Total liabilities 15,353 18,225 Commitments and contingencies — — Stockholders' equity: Preferred stock — — Common stock 2 2 Additional paid-in capital 304,352 302,541 Accumulated deficit (262,110 ) (240,869 ) Total stockholders' equity 42,244 61,674 Total liabilities and stockholders' equity $ 57,597 $ 79,899
Time Magazine
30-04-2025
- Health
- Time Magazine
Are Allergy Shots Worth It?
Nearly a third of American adults have some kind of allergy. If you're one of them, you're probably eager to find a solution. Allergy shots can provide long-lasting relief for certain non-food allergies, but there are some downsides. Is the time commitment, discomfort, and cost worth it? To help make that decision, here's the latest science behind allergy immunotherapy, how long the effects of the shots last, and what the future of allergy shots may hold. How do allergy shots work? Allergy shots have been around in one form or another since the 1910s. The idea is to desensitize an allergic person to a specific allergen, like pollen or cat dander. Your allergist will determine exactly what you're allergic to and then 'they make a specialized cocktail of allergens for that person,' says Dr. David Morris, chief of allergy and immunology at Dayton Children's Hospital. This cocktail contains very small, diluted amounts of those allergens and is then injected under your skin. 'This stimulates the immune system to feel like these things are normal and not foreign,' says allergist Dr. J. Allen Meadows, executive director of advocacy and governmental affairs at the American College of Allergy, Asthma & Immunology (ACAAI) and a pediatric allergist at the University of Alabama at Birmingham. After your shot, you'll be observed for about 30 minutes. 'This is because you do have the potential to have a reaction; we're giving you something injectable that you're allergic to,' Morris says. Serious reactions are rare but can be life-threatening, according to the American Academy of Allergy, Asthma, and Immunology (AAAAI). For the next several months, you'll get one or two shots a week containing increasing amounts of your allergens. This process helps you slowly build a tolerance to those allergens, Meadows says. After about seven months, your doctor will be able to space out your doses to every two weeks. Eventually, you get to what's considered a maintenance dose, which is when you can move to 'a shot a month at a high dose of what you're allergic to,' says otolaryngologist Dr. Marc Dubin, chief medical officer at ENT Speciality Partners. You'll likely stick to that once-a-month shot for three to five years. It can take as long as 12 months on your maintenance dose before you notice your symptoms are improving. In other words, allergy shots are definitely a time commitment. If you can make the time, however, then comes the payoff: 'It changes your immune system on a long-term basis,' Meadows says. You don't have to take any more shots, and you're free of your allergy symptoms—often for decades, he says. 'Some allergists will say the results last 'forever,' but forever is a long time, so I'm not as comfortable with that.' Who gets the best results? Anyone older than 5 can benefit from allergy shots, according to the AAAAI. People with pollen allergies tend to really appreciate the treatment effects, Morris says. 'For a patient's quality of life, pollen is the [most] noticeable one, because people are miserable during pollen season, and they notice they're no longer miserable,' he says. But if your symptoms are severe to start with, you might not see as much relief, Dubin says. You shouldn't get allergy shots if you currently have severe asthma symptoms, or if you're taking certain medications, including beta-blockers for high blood pressure and certain antidepressants, he adds. Allergy shots can also be used for people who are allergic to insect stings, but the process often takes longer and comes with more risks, Dubin says. If your symptoms start to come back after a course of allergy shots, you can go for another round. In fact, that's quite common in Morris' practice, considering he treats children: They might complete allergy shots in childhood and repeat the process in their 30s, he says. How much do allergy shots cost? Insurance coverage varies from person to person, but most people can expect to have some out-of-pocket costs for allergy shots—anywhere from $1,000 to $4,000 for office-visit copays and the treatment itself, Morris says. 'I have seen some of the insurers charge a copay for every shot,' Morris says. 'So if you're getting 28 shots—one a week for six months—and you've got a $25 copay, you start to do the math.' The cost alone can make allergy shots unrealistic for some people. What advancements are in the pipeline? Some health care providers are using shorter timelines for administering allergy shots, sometimes referred to as rapid desensitization or cluster or rush immunotherapy. Instead of getting one shot a week during your build-up phase, you might get several shots a week—even more than one shot in a day, Morris says. This expedites the time it takes to reach the maintenance phase to a few weeks or months. However, people generally have a higher risk of having a reaction on a faster allergy shot schedule, he adds. There is also a tablet form of allergen immunotherapy that works for people who are allergic to ragweed, some grasses, and dust. You let the tablet dissolve under your tongue at least three days a week. While under-the-tongue tablets and drops have been popular in Europe for some time, this method hasn't really caught on in the U.S., where most insurance providers don't cover it without prior authorization, Meadows says. While the tablets can make your mouth itchy, the risk of serious side effects is low. So another plus of this technique is you can do it yourself at home without needing to be monitored by your doctor, Dubin says. Although it's still in early research phases, Morris is intrigued by a new technique involving injecting allergens into a lymph node, where immune cells live, rather than under the skin, called intralymphatic immunotherapy. This approach kicks in quickly: It takes just three injections over two months. However, it requires an ultrasound to deliver the shot, so it takes some technical skill and the right equipment, he says. It's currently available at a limited number of health care facilities, but it's not yet approved by the U.S. Food and Drug Administration. 'Not all these are going to be right for every patient, [but] I'm excited for patients to get some quality-of-life improvements,' Morris says. 'I recommend people see a board-certified allergist and discuss these treatments and the risks and benefits and decide what's right for them.'
Yahoo
01-03-2025
- Health
- Yahoo
Positive results from the TEZSPIRE Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps
TEZSPIRE significantly reduced nasal congestion, polyp size and nearly eliminated the need for surgery in patients with chronic rhinosinusitis with nasal polyps WAYPOINT data published in New England Journal of Medicine and highlighted as late-breaking oral presentation at AAAAI/WAO 2025 WILMINGTON, Del., March 01, 2025--(BUSINESS WIRE)--Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen's TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.1,2 These data were published in the New England Journal of Medicine and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.1,2 Treatment with TEZSPIRE significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52 compared to placebo.1,2 Improvements in NPS were observed as early as week four and NCS as early as week two (the first post-treatment assessment respectively) and were sustained through week 52.1 Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.1 Importantly, TEZSPIRE significantly reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% ( p<0.0001) compared to placebo.1 Dr Joseph Han, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the trial, said: "Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids. The WAYPOINT results are clinically meaningful and suggest that tezepelumab could greatly reduce the burden of nasal polyps for patients by nearly eliminating the need for future surgery and corticosteroid use and by significantly reducing nasal polyp size and congestion." Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said, "The WAYPOINT results demonstrate the potential for TEZSPIRE to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps. With its first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases." Table M1: Summary of co-primary and key secondary efficacy endpoints1,2 Endpoint Tezepelumab (n=203) Placebo (n=205) Difference vs. Placebo (95% CI) Co-primary endpoints Total nasal polyp score (range 0-8)* -2.458 (0.114) -0.392 (0.118) -2.065 (-2.389, -1.742) p<0.0001** Nasal congestion score (range 0-3)* -1.743 (0.062) -0.715 (0.064) -1.028 (-1.201, -0.855) p<0.0001** Key secondary endpoints Assessed in the overall trial population Time to first nasal polyp surgery decision (% patients)*** 0.5 (0.0, 2.5) 22.1 (16.4, 28.2) 0.02 (0.00, 0.09) p<0.0001** Time to first systemic glucocorticoid use (% patients)*** 5.2 (1.1, 14.7) 18.3 (13.3, 24.1) 0.12 (0.04, 0.27) p<0.0001** Time to nasal polyp surgery decision and/or systemic glucocorticoid use (% patients)*** 5.7 (1.3, 15.0) 30.6 (24.2, 37.1) 0.08 (0.03, 0.17) p<0.0001** Loss of smell score (range 0-3)* -1.26 (0.06) -0.26 (0.06) -1.00 (-1.18, -0.83) p<0.0001** Sino-Nasal Outcome Test-22 (SNOT-22) total score (range 0-110)* -45.02 (1.81) -17.76 (1.84) -27.26 (-32.32, -22.21) p<0.0001** Sinus Computed Tomography Lund–Mackay (CT-LMK) score (range 0-24)* -6.27 (0.24) -0.55 (0.24) -5.72 (-6.39, -5.06) p<0.0001** Total Symptom Score (TSS) (range 0-24)* -10.39 (0.40) -3.50 (0.41) -6.89 (-8.02, -5.76) p<0.0001** Key secondary endpoint Assessed in a subset of patients with co-morbid asthma or nonsteroidal anti-inflammatory drug exacerbated respiratory disease Pre-bronchodilator forced expiratory volume in 1 second (FEV1 in liters)* 0.02 (0.04) 0.03 (0.04) -0.01 (-0.12, 0.11) p=0.9362 *LS mean change (SE) from baseline at Week 52 **Denotes statistically significant at 0.01 level after adjustment for multiplicity. Unadjusted P-values are presented *** % patients from Kaplan Meier estimate (95% confidence interval) is provided for each treatment group, hazard ratio (95% confidence interval) is presented for the difference vs placebo. TEZSPIRE was generally well tolerated in patients with CRSwNP and had a safety profile consistent with its approved severe asthma indication.1,2 The most frequently reported adverse events for TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis and upper respiratory tract infection.1 There were no clinically meaningful differences in safety results between the TEZSPIRE and placebo group.1 TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and over 60 countries across the globe.3-5 It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.3,4 Regulatory filings for tezepelumab in CRSwNP are currently under review by regulatory authorities in multiple regions. INDICATION AND LIMITATION OF USE / ISI TEZSPIRE® (tezepelumab-ekko) INDICATION TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain. USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Please see full Prescribing Information, including Patient Information and Instructions for Use. You may report side effects related to AstraZeneca products. Notes Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) CRSwNP is a complex inflammatory disorder, characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.6,7 Nasal polyps and the accompanying inflammation can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.8-10 Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics.7,10-16 Phase III WAYPOINT trial WAYPOINT was a double-blind, multi-centre, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.1,2,17 Participants received tezepelumab or placebo, administered via subcutaneous injection.1,2,17 The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.1,17 TEZSPIRE TEZSPIRE® (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic, and other types of epithelial-driven inflammation associated with severe asthma and other inflammatory diseases.18,19 TSLP is released in response to multiple epithelial triggers and insults (including allergens, viruses, bacteria, smoke, air pollution and other airborne particles) associated with asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other diseases.19,20 Expression of TSLP is increased in these patients and has been correlated with disease severity.10,18 Blocking TSLP can prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of exacerbations and improved disease control.18,19,21 Tezepelumab acts at the top of the inflammatory cascade and research indicates that targeting TSLP released by the airway and gastrointestinal epithelium may be a potential approach to treating other diseases in the future.18,22,23 TEZSPIRE is approved in the US, the EU and over 60 countries for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.3-5 Beyond CRSwNP, tezepelumab is also in development for other potential indications including COPD and EoE.24,25 In October 2021, tezepelumab was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of EoE. In July 2024, the US FDA granted a Breakthrough Therapy Designation for tezepelumab for the add-on maintenance treatment of patients with moderate to very severe COPD characterized by an eosinophilic phenotype. Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit inventor royalty to Amgen. AstraZeneca continues to lead development, and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. Please visit and follow the Company on social media @AstraZeneca References Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025. Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology /World Allergy Organization Joint Congress 2025 (28 February – 03 March). TEZSPIRE (tezepelumab) US prescribing information. Available at: [Last accessed: February 2025]. TEZSPIRE (tezepelumab) Summary of Product Characteristics. Available at: [Last accessed: February 2025]. AstraZeneca plc. TEZSPIRE approved in Japan for the treatment of severe asthma. Available at: [Last accessed: February 2025]. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016; 4 (4): 621-628. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: [Last accessed: February 2025]. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4 (4): 565-572. Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012; 37 (4): 276-282. Chen S et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911. Xolair (omalizumab) Summary of Product Characteristics; Available at: [Last accessed: February 2025]. Xolair (omalizumab) US prescribing information; Available at: [Last accessed: February 2025]. Nucala (mepolizumab) Summary of Product Characteristics. Available at: [Last accessed: February 2025]. Nucala (mepolizumab) US prescribing information; Available at: [Last accessed: February 2025]. Dupixent (dupilumab) Summary of Product Characteristics. Available at: [Last accessed: February 2025]. Dupixent (dupilumab) US prescribing information; Available at: [Last accessed: February 2025]. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: [Last accessed: February 2025]. Corren J, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936-946. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595. Zhang M, et al. Hypoxia induces the production of epithelial-derived cytokines in eosinophilic chronic rhinosinusitis with nasal polyps. Int Immunopharmacol. 2023;121:110559. Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018;200: 2253–2262. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809. Laidlaw TM et al. Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR. J Asthma Allergy. 2023 Sep 4:16:915-932. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: [Last accessed: February 2025]. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: [Last accessed: February 2025]. View source version on Contacts Media Inquiries Fiona Cookson +1 212 814 3923Jillian Gonzales +1 302 885 2677US Media Mailbox: usmediateam@ Sign in to access your portfolio
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28-02-2025
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Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)
Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presented New analyses of 52-week data from Phase III REMIX pivotal trials of investigational remibrutinib, demonstrating impact in key clinical outcomes for patients with CSU also to be presented Regulatory submissions for remibrutinib as a treatment for CSU on track for filing in 1H 2025 EAST HANOVER, N.J., Feb. 28, 2025 /PRNewswire/ -- Novartis announced today it will present data from 17 abstracts, including investigator-initiated trials, across its immunology portfolio at the 2025 American Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and the 2025 American Academy of Dermatology (AAD) Annual Meeting. Data presented at the congresses include long-term urticaria control, sleep, and activity analyses from the Phase III REMIX-1 and REMIX-2 studies evaluating investigational remibrutinib for the treatment of chronic spontaneous urticaria (CSU). Additionally, long-term data from the Cosentyx® (secukinumab) Phase III SUNSHINE and SUNRISE trials in patients with hidradenitis suppurativa (HS) and patient-reported outcomes from a Phase II trial evaluating remibrutinib in HS will be presented. "Conditions like CSU and HS are more than just skin deep, often having a profound impact on patients' daily lives and activities," said Angelika Jahreis, Global Head, Development, Immunology, Novartis. "These data at AAAAI and AAD highlight our continued commitment to reimagine medicine and address treatment gaps for people with immune-mediated diseases. We are particularly excited about the potential for remibrutinib as a novel oral treatment for patients with CSU who remain symptomatic on antihistamines." These CSU data will support regulatory submissions in the first half of 2025. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, including chronic inducible urticaria (CIndU), HS, and food allergy. Key abstracts accepted by AAAAI include: Abstract Title Abstract Number/ Presentation Details Remibrutinib The Impact of Remibrutinib on Urticaria Control in Patients with Chronic Spontaneous Urticaria: Long-term Results from the REMIX-1/-2 Phase 3 Trials Abstract #598Oral PresentationSaturday, March 12:35 – 2:45 PM PST Remibrutinib Treatment Has No Clinical Impact on Mean Blood Cell Counts in Patients With Chronic Spontaneous Urticaria: Pooled Safety Analysis From REMIX-1 and REMIX-2 Studies Abstract #592Poster PresentationSunday, March 29:45 – 10:45 AM PST Key abstracts accepted by AAD include: Abstract Title Abstract Number/ Presentation Details Remibrutinib Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies Abstract #62278e-Poster with Oral PresentationFriday, March 74:55 – 5:00 PM EST Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 Abstract #P62280e-Poster Presentation Effects of Remibrutinib Treatment on Ambulatory Blood Pressure in Adult Patients With Chronic Spontaneous Urticaria (CSU) Abstract #62284e-Poster Presentation Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study Abstract #62279e-Poster Presentation Cosentyx The impact of continuous secukinumab treatment between weeks 52–104 on draining tunnels in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #63334e-Poster Presentation The impact of continuous secukinumab treatment between weeks 52–104 on HiSCR75, HiSCR90, and HiSCR100 in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #62149e-Poster Presentation Efficacy of secukinumab uptitration from every 4 weeks to every 2 weeks dosing between weeks 52-104 in week 52 HiSCR non-responder patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #63451e-Poster Presentation The impact of continuous secukinumab treatment through week 104 on efficacy outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials Abstract #64857e-Poster Presentation The impact of continuous secukinumab treatment through week 104 on patient reported outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials Abstract #64674e-Poster Presentation Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. # # # Novartis Media RelationsE-mail: Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: View original content: SOURCE Novartis Pharmaceuticals Corporation Sign in to access your portfolio
