Latest news with #atopicDermatitis
National Post
5 days ago
- Business
- National Post
AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575
Article content ABCL575 is an Fc-silenced, half-life extended investigational antibody medicine that is being developed for the treatment of atopic dermatitis Article content Article content VANCOUVER, British Columbia — AbCellera (Nasdaq: ABCL) today announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L) that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions. Article content The Phase 1 study is anticipated to begin in Q3 of 2025 and will evaluate the safety and pharmacokinetics of ABCL575 administered subcutaneously in healthy participants. Article content About ABCL575 Article content ABCL575 is an investigative monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions. ABCL575 binds OX40L to disrupt OX40/OX40L signaling, a regulator of inflammatory pathways in AD. It has been engineered with a modified Fc domain to support Fc-silencing and half-life extension. In preclinical studies, ABCL575 shows potent inhibition of T cell-mediated inflammatory pathways, favorable tolerability, and an in vivo half-life that is expected to support less frequent dosing than current clinical-stage molecules. A Phase 1 clinical trial is anticipated to begin in Q3 of 2025. Article content About AbCellera Biologics Inc. Article content AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera's platform integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit Article content This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Article content In some cases, you can identify forward-looking statements by the words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors are described under 'Risk Factors,' 'Management's Discussion and Analysis of Financial Condition and Results of Operations,' and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Article content Article content Article content Article content Article content Article content
Medscape
5 days ago
- General
- Medscape
Childhood AD Not Linked to Executive Function Deficits
A cohort study of children in the United Kingdom found that early childhood atopic dermatitis (AD), especially when mild, is not associated with executive function (EF) deficits in middle childhood. METHODOLOGY: Researchers analyzed 11,373 children (51.5% boys; > 95% White individuals) from the UK-based Avon Longitudinal Study of Parents and Children, with parental reports of AD activity and severity in their children between ages 6 and 81 months. AD activity and severity of children were assessed using maternal questionnaires at two or more of seven timepoints between 6 months and 7 years of age, focusing on itchy, dry skin rash in joints and creases, such as behind the knees. At 81 months, data was available for 8208 children, 81% had no AD and 19% had varying degrees of AD activity and severity. Using latent class mixed modeling, researchers classified children into five distinct early childhood AD trajectories: Unaffected/rare (62.90%), early onset resolving (1.09%), persistent mild (31.35%), persistent moderate to severe (0.93%), and worsening (3.74%). EF, specifically attention regulation, inhibition, and working memory, was measured at ages 8, 10, and 11 years, adjusted for covariates. TAKEAWAY: No statistically significant differences were detected across AD trajectories in selective attention, divided attention, and attentional control at ages 8 and 11 years, inhibition at age 10 years, and working memory at ages 8 and 10 years. Similarly, no statistically significant associations were observed between AD severity status at 81 months and EF outcomes in middle-childhood. IN PRACTICE: 'The role of EF in the relationship between childhood AD and neuropsychological outcomes is an understudied area,' the authors wrote, 'but together with prior research, the current study supports the conclusion that EF impairment is not a major mechanism driving this relationship, at least in a sample of nonadolescent children with largely mild AD.' SOURCE: The study was led by Elle Kim, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on May 2025 in Journal of the European Academy of Dermatology and Venereology . LIMITATIONS: Only a small portion of the study population experienced moderate or severe disease, which limited the statistical power to detect effects in more severe cases. Other limitations included potential selection bias, lack of information about treatments for AD, and limitation of generalizability to non-UK populations. DISCLOSURES: The study was supported by the National Institutes of Health. Some authors reported receiving research and fellowship funding from and having other ties with various sources, including Pfizer, Sun Pharmaceuticals, La Roche Posay. One author also declared holding patents, being a deputy editor, and being a member of the Board of Directors for the International Psoriasis Council and the Medical Dermatology Society.
CNA
16-05-2025
- Health
- CNA
Living with eczema is harder than I thought, but it's taught me to celebrate the small wins
In April 2023, I was looking forward to my first ever snowboarding trip. I'd wanted to do it for a while, but had always put it off because I had reservations with dry weather – a necessary caution for me due to my eczema. Eczema first appeared on the skin around my eyes when I was 16. Later on, I was diagnosed with atopic dermatitis on other parts of my body. The usual suspects would be the crooks of the elbows, behind the knees, armpits – any areas of the body extra susceptible to trapped perspiration. Earlier this year, I was also diagnosed with dyshidrotic eczema, also known as pompholyx eczema. It manifests on the hands and feet, and is associated with excessive hand-washing, use of sanitisers, and emotional stress. Mine manifests on my hands, and is exacerbated in dry weather. Because of that, spending 10 days in the snowy mountains is a lot less fun for me than the average person. Nevertheless, I had the belief that I could do anything as long as I put my mind to it. I decided I wouldn't let anything stop me from checking snowboarding off my bucket list, and booked my plane ticket to France. Each day, we went for snowboarding lessons and each evening I would wince in the shower, trying to wash my hair with my cracked fingertips. When I went to bed each night, I would carefully position my hands palms facing up so I wouldn't dirty my sheets with the sticky moisturiser I slathered on to heal and soothe my inflamed skin. Honestly, the trip was great and I made many new friends. But I spent all 10 days smiling through my pain – my constant, relentless pain. I still believed I could do anything I wanted if I put my mind to it. But on that trip, I realised: Just because I can, doesn't mean I should. When I returned to Singapore, my energy levels crashed. I had to spend a few days 'hibernating', recuperating the physical, mental and emotional energy drained from me over 10 days of coping with my aggravated skin problems. So much for a holiday. ALL DAY, EVERY DAY Eczema is fairly common in Singapore, affecting one in five children and one in 10 adults. I'm just one of hundreds of thousands that suffer from this condition – and this number is only increasing with each year. For more than 10 years, eczema has been a constant (if somewhat inconsistent) presence in my life. But as I grew older, I started noticing that it was taking longer and longer to heal between flare-ups. In 2021, at age 26, I had yet another flare-up on my hands. I defaulted to my usual management strategy – topical steroid creams and moisturiser. But two to three years on, I realised that my skin had never seemed to fully recover. In fact, it was only getting worse each time. In January this year, strange-looking blisters called vesicles started appearing on my hands, taking my discomfort to a new peak. Getting on with my life became cumbersome and painful. Even the simplest of tasks became agonising ordeals – tying my shoelaces, preparing meals, cleaning, and so on. The worst was whenever I had to wash my hands or take a shower. Water and soap would seep into the cracks on my fingers and hands, and every single time, it would sting and burn. On top of this, my hands itched several times throughout each day. I had to start dedicating more and more energy to just ignoring it; a simple lapse in willpower might result in me scratching and breaking my skin. I often find myself unable to control myself in sleep, so when I wake up the next day, I feel a wave of guilt but also lethargy. I have to force myself to stay alert throughout the day, to get through my tasks at work or at home. I become more anxious when my condition worsens, which makes it even harder to heed my doctor's advice to avoid stress. Enduring this discomfort every single day sapped my energy and left me exhausted and empty. When I was younger, I would tell myself that I just needed to 'push through' it, but that only led me to burnout. Nowadays, I'm much more prudent with my stores of energy. But it's easy to fall back into the trap of thinking that I need to be more productive, that I need to push myself to the limit to achieve more. After all, so many narratives in the public eye seem to exalt such actions. A HEAVY BURDEN TO BEAR The reality is that eczema, as well as countless other chronic illnesses, places a huge mental load on sufferers, impacting and shaping their lifestyles. The cognitive and emotional effort involved in managing daily life, especially household chores, multiplies manifold but remains invisible. I'd read about other patients with very severe eczema who need round-the-clock care, special baths and a cocktail of pills to even survive. Influencer Tammie Ong doesn't have eczema, but has several other incurable, chronic conditions – she even has to ingest nutrients through a tube. I can scarcely imagine the mental load her and other chronic disease sufferers have on top of the toll exacted by their physical impairments and debilitations. When I cook, I have to take extra effort to find recipes that require minimal prep. In buying groceries, I fork out more for pre-chopped ingredients to avoid having to handle and wash them too much. I try to stick to exercise options that don't require me to use my hands a lot – standing HIIT workouts, for instance, or stair training. I had to get a strap to carry my phone everywhere with me, for the days where digging into my pockets is simply too painful. And of course, I worry often about costly medical fees. All this greatly frustrated me at first. But now, I'm learning to come to terms with my new reality, and focus on the positives. I'm aware that I'm in a much better position than many others, for one. I count myself lucky that there are varied treatment options that are accessible to me, and that I'm able to work in an air-conditioned environment. My loved ones patiently support me and pick up the slack – my mother and grandfather always pack extra portions of food for me when I visit, and my partner pre-cuts my fruits and veggies so I can have easy access to them. I've also learnt to start celebrating my own efforts, no matter how small the task seems. I'm learning to applaud myself for keeping my spaces clean, and for working out even though I could easily call it a day on account of my eczema. One of the advantages of being stubbornly determined is that it still doesn't completely stop me from doing what I want. At the start of 2025, I went on my second snowboarding trip. It was a lot more painful than the first, given that my eczema has intensified over the last few years. Everything was worse: Showers were more unbearable, the dry air seemed to siphon moisture out of my skin even through layers of moisturiser, and I had many teary fits of sheer frustration. Strangely enough, I still don't regret it. It taught me that there's no shame in listening to my body, and letting go of something I want to pursue so I can care for my well-being. I'm sure it won't be the last snowboarding trip of my life – but for now I need to focus on taking care of myself. Even though it's goodbye for now, I'm looking forward to the many other new experiences awaiting me. Kora Fong is a digital analyst at CNA Digital.
Medscape
16-05-2025
- Health
- Medscape
Atopic Dermatitis Linked to Higher Odds of NMSC
SAN DIEGO — Patients with atopic dermatitis (AD) are at a significantly higher risk for nonmelanoma skin cancer (NMSC), although the overall risk remains low, a new retrospective database study found. Compared with patients without AD, the odds of NMSC in patients with AD were 1.53 times higher in an adjusted analysis (odds ratio [OR], 1.53; 95% CI, 1.17-2.01; P < .05), according to a study of 2021 national survey data presented here at the annual meeting of the Society for Investigative Dermatology. 'The strength of that association surprised us, as well as the consistent findings across various demographic groups. It adds weight to the theory that AD isn't just a quality-of-life disease but may have more serious systemic consequences,' said study lead author Lara Shqair, medical student at the Icahn School of Medicine at Mount Sinai, New York City, in an interview with Medscape Medical News . Other studies have examined possible relationships between AD and NMSC. A 2024 study using US claims data linked any AD and moderate to severe AD to higher rates of NMSC (relative risk, 1.32; 95% CI, 1.30-1.35 and 1.36; 95% CI, 1.12-1.65, respectively). And a 2023 study found that among various malignancies in patients with moderate to severe AD, incidence rates were highest for NMSC (moderate AD: 4.6; 95% CI, 3.9-5.5; severe AD: 5.9; 95% CI, 3.8-9.2). However, 'what was missing was a large, nationally representative study that could give us a clearer picture of this relationship in the general United States population,' said Shqair, who presented the results at the meeting. That's where the new research comes in. Shqair and colleagues evaluated the association between AD and NMSC via 29,116 participants — 7.4% with self-reported AD and 2.7% with NMSC — in the 2021 National Health Interview Survey. Overall, an estimated 3.6 million cases of basal cell carcinoma and 1.8 million cases of squamous cell carcinoma — the two most common types of NMSC — are diagnosed in the United States each year. In an unweighted analysis, 2.0% of the non-AD population and 2.8% of the AD population had NMSC ( P < .05). After researchers weighted the data for age, sex, race, insurance type, education level, and NMSC prevalence, they determined that patients with AD had a higher risk for NMSC. Why might AD and NMSC be related? One possibility is that chronic skin inflammation promotes cancer through local immune dysregulation, Shqair said. Another possibility is that systemic immunosuppressive treatments could increase their risk, 'and there's also the role of barrier dysfunction and transcutaneous sensitization, potentially allowing more exposure to carcinogens,' she added. In the big picture, she said, excess risk is likely due to 'a combination of biological, treatment-related, and behavioral factors.' The researchers also found that women (63% of the AD cases) and patients with private insurance (64%) were more likely to have AD. In their adjusted analysis, AD was linked to higher levels of education (some college education, OR, 0.47; 95% CI, 1.18-1.83; P < .05, and holding a professional degree (OR, 2.41; 95% CI, 1.85-3.13; P < .05) vs high school degree or lower. 'People with more education may be more proactive about their health and more likely to seek dermatologic care,' Shqair said. Other factors may be at play 'such as differences in health literacy, insurance coverage, trust in the medical system, and the ability to take time off work or afford specialized care.' The study's overall message is that 'dermatologists should be aware that patients with AD, especially those with severe or long-standing disease, might be at elevated risk for NMSC,' she said. The new study complements previous analyses and is consistent with their findings, said Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Connecticut, who was not involved in the research. The apparent extra risk 'indicates patients with AD may require careful education on sun protection and may need to undergo routine skin screenings on a consistent basis,' Bunick told Medscape Medical News . 'I recommend a combination of education around risk of NMSC and the need for sun protection and the strict avoidance of tanning beds.'
Associated Press
12-05-2025
- Business
- Associated Press
Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results
Phase 2 APEX trial of APG777 in atopic dermatitis advancing with interim Part A 16-week data expected in mid-2025 and Part B actively enrolling First patient dosed in Phase 1b trial of APG777 in mild-to-moderate asthma with readout expected in 1H 2026 APG279 on track to initiate Phase 1b head-to-head trial vs DUPIXENT in 2025 with readout expected in 2H 2026 Positive interim Phase 1b readout of APG808 in patients with mild-to-moderate asthma demonstrated rapid, robust and sustained suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma $681.4million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided business updates, pipeline progress and reported first quarter 2025 financial results. '2025 is poised to be a transformational year for Apogee, and we are pleased with the strong execution in the first quarter as we continue to advance therapies with the goal of reshaping the standard of care for patients living with I&I diseases,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'We have made significant progress in our Phase 2 APEX trial of APG777, which is actively enrolling Part B and on track for the interim 16-week readout from Part A mid-year. Momentum continues across our programs, driven by the initiation of our Phase 1b trial of APG777 in patients with mild-to-moderate asthma, today's announcement of positive interim clinical trial results from our Phase 1b trial of APG808 in patients with mild-to-moderate asthma, as well as the positive Phase 1 interim readout for APG990, which exceeded all trial objectives and unlocked the potential for dosing APG279 (APG777 + APG990) two- to four- times per year with a single 2 mL co-formulated injection. Following these encouraging results from APG990, we are advancing our first-in-class combination strategy with plans to initiate a head-to-head Phase 1b study of APG279 versus DUPIXENT in AD later this year. With a very strong cash position and multiple catalysts across our portfolio in the months ahead, we are looking forward to an exciting and productive 2025 and 2026.' New independent market research reinforces APG777's potential to become a market leader in the rapidly expanding AD biologic space: Apogee conducted third-party quantitative market research in April 2025 and asked US patients and physicians the likelihood that they would switch to APG777 from their current or previous biologic assuming APG777 had similar efficacy and overall results to DUPIXENT and an every 3-month, or quarterly, injection maintenance schedule. 'Based on the recent market research we commissioned, APG777's potential quarterly dosing is highly preferred by both physicians and patients to other available options. Physicians expressed strong interest in both initiating new-to-biologic patients to APG777 as well as switching patients already on biologics to APG777, assuming comparable efficacy and safety to current biologics,' said Jeff Hartness, Chief Commercial Officer of Apogee. 'The AD biologic market is expanding rapidly—with year-to-date growth of 23% in total prescriptions and 44% in new-to-brand prescriptions—and new entrants are accelerating the shift from topicals to biologics. We believe APG777 is well positioned to transform the AD treatment landscape and significantly improve the quality of life for patients living with moderate-to-severe AD.' Pipeline Highlights and Upcoming Milestones First Quarter 2025 Financial Results About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Forward Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990) in AD, the Phase 2 trial of APG777 in EoE, and the Phase 1 trial of APG333 in healthy volunteers; the expected timing of and results from its clinical trials, including data from Part A and Part B of its Phase 2 trial of APG777 in AD, Phase 1b trial of APG279 in AD, Phase 1 trial of APG333 in healthy volunteers, Phase 1b trial of APG777 in asthma; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, APG990, APG333, APG808, Apogee's other product candidates, including combination therapies, and any other potential programs; its planned business strategies; its expected timing for future pipeline updates; and its expectations regarding the time period over which Apogee's capital resources will be sufficient to funds its anticipated operations. Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company's control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee's Annual Report on 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB Media [email protected]
