Latest news with #NCFB
WebMD
6 days ago
- Health
- WebMD
Brinsupri: First Once-Daily Tablet for Non-Cystic Fibrosis Bronchiectasis
What Is Brinsupri, and Why Does It Matter? Brinsupri (brensocatib) is a new oral medicine approved to treat a long-term lung disease known as non-cystic fibrosis bronchiectasis (NCFB) in adults and children ages 12 or older. It works by blocking an enzyme called DPP1, which normally activates certain proteins in white blood cells that cause inflammation in the lungs. By stopping this process, Brinsupri may help reduce lung damage and lower the number of flare-ups that result in worsening cough, increased mucus, shortness of breath, and fatigue that you may experience with NCFB. Brinsupri is the first and only medicine approved by the FDA that is made specifically for NCFB, which affects about 500,000 people in the U.S. and many more around the world. NCFB widens and damages the airways in your lungs, making it harder to clear mucus. This can lead to trouble breathing and frequent lung infections that often require antibiotics or hospital care while also affecting a person's emotional health and overall well-being. Until now, there were no approved treatments that directly targeted the inflammation behind this disease. Why Was It Approved? Brinsupri was approved because studies showed it was safe and effective in reducing the yearly number of flare-ups in people with NCFB. In one study, people who took Brinsupri (10 milligrams or 25 milligrams) had about 20% fewer flare-ups over a year than those who took a placebo. It also helped delay the time to the first flare-up and increased the number of people who didn't have any flare-ups during the study period. The higher dose also slowed down the worsening of lung function. The most common side effects included upper respiratory tract infections, headaches, skin rashes, dry or thickened skin, and high blood pressure, along with gum or dental problems. Less common side effects included changes in liver test results and thinning hair. The studies included adults and children aged 12 and older. Brinsupri has not been studied in children under 12, so it's not known if it's safe or effective for that age group. What Do I Need to Know? Brinsupri is a tablet you take once a day. It comes in 10-milligram and 25-milligram strengths and can be taken with or without food. If you miss a dose, just take your next dose at the usual time the next day. Don't take two doses at once to make up for a missed one. This medicine is now available in the U.S. through a specialty pharmacy network. Talk to your health care provider to see if Brinsupri is right for you, especially if you have skin or dental issues. Brinsupri may raise the risk for skin, gum, or tooth problems, so regular checkups with a dermatologist and dentist are a good idea. It is not known if Brinsupri affects how well certain vaccines work. Talk to your health care provider if you are planning to take a live, attenuated vaccine before or during your treatment. Let your health care provider know about all the medicines you take. Brinsupri may interact with other drugs, especially those that affect how your liver processes medicine. There's no safety information yet about using Brinsupri during pregnancy or while breastfeeding, so be sure to talk with your health care provider if you are pregnant, planning to become pregnant, or nursing.
Yahoo
7 days ago
- Business
- Yahoo
FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease
The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated's (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri is the first and only FDA-approved treatment for NCFB, a chronic lung condition characterized by permanently widened and damaged airways (bronchi), leading to persistent mucus production, recurrent infections, and difficulty breathing. There are approximately 500,000 people in the U.S. diagnosed with NCFB. The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, as compared to placebo. Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received Brinsupri 25 mg experienced a statistically significantly less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW. In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. Price Action: INSM stock is up 6.20% at $119.89 at the last check on Tuesday. Read Next:Photo: Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? INSMED (INSM): Free Stock Analysis Report This article FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
7 days ago
- Health
- Malaysian Reserve
FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease
— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage — — BRINSUPRI 10 mg and 25 mg Doses Approved for the Treatment of NCFB — — BRINSUPRI, a First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation, Is Available by Prescription Through a Comprehensive Specialty Pharmacy Network — — Insmed to Host Investor Conference Call Today at 12:00 PM ET — BRIDGEWATER, N.J., Aug. 12, 2025 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. BRINSUPRI is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. This press release features multimedia. View the full release here: 'This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis,' said Doreen Addrizzo-Harris, M.D., FCCP, the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis and NTM Program, and ASPEN investigator. 'For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care.' There are approximately 500,000 people in the U.S. diagnosed with NCFB, and it is estimated that millions more are living with this disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. A hallmark of bronchiectasis is frequent exacerbations, or flares, when symptoms worsen, such as coughing, increased mucus, shortness of breath and fatigue. 'Non-cystic fibrosis bronchiectasis deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being,' added Elisha Malanga, Executive Director of the Bronchiectasis and NTM Association. 'Many patients experience frequent flares, which can disrupt daily life and potentially lead to disease progression. The FDA approval of brensocatib represents a significant and long-awaited advancement as the first approved therapy for non-cystic fibrosis bronchiectasis. Our hope is that treatments like this will enable people with bronchiectasis to manage their condition.' This approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking BRINSUPRI 10 mg or 25 mg had a 21.1% and 19.4% reduction in annual rate of exacerbations respectively, as compared to placebo. Both dosage strengths of BRINSUPRI also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received BRINSUPRI 25 mg experienced statistically significant less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety of BRINSUPRI was also evaluated in both studies. The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW. 'The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,' said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. 'By keeping patients at the center of everything we do, we have once again delivered a first-in-class medicine for a disease with no prior approved treatments. This is an incredible achievement in medicine. We're deeply grateful to the patients, providers, and advocates who made this possible – this is just the beginning of what we can accomplish together for this community.' BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. BRINSUPRI is the first approved therapy to address the underlying inflammatory process of NCFB. In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the Company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. BRINSUPRI is now available in the U.S. by prescription through a comprehensive specialty pharmacy network. Conference Call Information Insmed will host a conference call today at 12:00 PM Eastern Time to discuss the FDA approval. The call can be accessed by dialing (888) 210-2654 (U.S. and Canada) or (646) 960-0278 (international) and entering the conference ID number 6364918. The call will also be webcast live on the Company's website at A replay of the conference call will be accessible approximately two hours after its completion through August 19, 2025, by dialing (800) 770-2030 (domestic) or (609) 800-9909 (international) and referencing conference ID number 6364918. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at About BRINSUPRI™ (brensocatib) BRINSUPRI™ (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in other neutrophil-mediated diseases. About InLighten Patient Support Program Insmed is committed to providing access to its products by providing eligible patients with financial assistance options. Patients using Insmed products may also enroll to receive ongoing education and support through its inLighten Patient Support Program. About ASPEN ASPEN was a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFB). As part of the ASPEN study's conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. About WILLOW WILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with non-cystic fibrosis bronchiectasis (NCFB). WILLOW was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFB who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm. About Bronchiectasis Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Most bronchiectasis cases in adults are non-cystic fibrosis bronchiectasis. Today, approximately 500,000 patients in the U.S., 600,000 patients in the EU5 (France, Germany, Italy, Spain, and UK), and 150,000 patients in Japan have been diagnosed with NCFB. Outside the U.S. there are currently no approved therapies specifically targeting bronchiectasis in these regions. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. Live Attenuated Vaccines It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. ADVERSE REACTIONS The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions. Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. Alopecia In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. Please see full Prescribing Information. INDICATION BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending four consecutive years as the No. 1 Science Top Employer. Visit to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. 'Forward-looking statements,' as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as 'may,' 'will,' 'should,' 'could,' 'would,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'predicts,' 'intends,' 'potential,' 'continues,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to successfully commercialize BRINSUPRI in the U.S. or to maintain U.S. approval for BRINSUPRI; failure to obtain, or delays in obtaining, regulatory approvals for BRINSUPRI in Europe or Japan, including the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the healthcare community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the ASPEN study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; failure to successfully conduct future clinical trials for brensocatib, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; failure to obtain regulatory approval for potential future brensocatib indications; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, 'Risk Factors,' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan DunnVice President, Investor Relations(732) Media: Claire MulhearnVice President, Corporate Communications(862) 842-6819media@ View original content:
Miami Herald
15-07-2025
- Business
- Miami Herald
AATec Medical and Northway Biotech Announce Partnership to Develop Industrial Production Process for ATL-105 Targeting Lung Disease
Partnership established to develop and scale production of ATL-105, a novel recombinant version of alpha-1 antitrypsinLead indication is non-CF bronchiectasis; ATL-105 targets disease drivers through a broad multimodal mechanism of action VILNIUS, LT / ACCESS Newswire / July 15, 2025 / AATec Medical GmbH ("AATec"), a biotech company developing a multi-product platform for the treatment of respiratory diseases, and Northway Biotech ("Northway Biotech" or "NBT"), a global Contract Development and Manufacturing Organization (CDMO), today announced a partnership for manufacturing process development and analytical development of AATec's lead product candidate, ATL-105, a proprietary, inhaled therapy based on recombinant alpha-1 antitrypsin (AAT) for non-cystic fibrosis bronchiectasis (NCFB). Under the agreement, Northway Biotech will leverage its expertise in biologics manufacturing to develop and scale the production process for ATL-105 using the Pichia pastoris expression system. "With this partnership, we are establishing a robust and scalable production process for ATL- 105, laying the foundation for consistent quality for clinical development and commercial use," says Rüdiger Jankowsky, PhD, co-founder and CEO of AATec, and adds: "ATL-105 represents a new generation of inhaled biologics, combining anti-protease, anti-inflammatory, and antiinfective properties in one molecule. Delivered directly to the lungs, it enables fast, targeted action with minimal systemic exposure. We believe ATL-105 can redefine care in respiratory diseases with high medical need, such as non-CF bronchiectasis." "We are excited to support AATec in progressing towards clinical trials", shares Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech. "AATec is advancing a promising therapeutic solution addressing significant unmet medical needs, supported by a highly capable and dedicated team. With our decades of expertise in microbial systems, we are well-positioned to scale this program efficiently and deliver quality at every step." "We have recognized the opportunity to support a program that could meaningfully advance care for patients with respiratory diseases," adds André Markmann, PhD, VP of Business Development at Northway Biotech. "Inhaled protein therapies are gaining significant traction, and ATL-105 stands out as one of the most promising approaches in this area." AATec develops ATL-105 to treat NCFB, a chronic inflammatory respiratory condition which affects millions of people worldwide. This debilitating disease is marked by dilated bronchi, persistent inflammation, frequent airway infections and impaired mucus clearance. In addition to NCFB, ATL-105 has therapeutic potential for a broader range of inflammatory and infectious respiratory diseases, such as COPD, ARDS and other indications, reflecting the versatility of its anti-inflammatory, immunomodulatory, and anti-infective properties. About AATec Medical AG AATec Medical GmbH is a biotechnology company developing a product platform based on a novel recombinant version of alpha-1 antitrypsin (AAT) for the treatment of respiratory inflammatory diseases, airway infections and rare diseases. The company has successfully demonstrated proof-of-principle in several indications and is currently preparing for a proof-ofconcept clinical trial with the first product candidate ATL-105 for inhaled application in non-CF bronchiectasis. AATec was founded by a seasoned interdisciplinary team with long-standing experience in clinical research, biopharmaceutical development and product industrialization. For further information, please visit and follow AATec on LinkedIn. About Northway Biotech Northway Biotech is a leading CDMO specializing in protein-based biologics and gene therapies, offering comprehensive, end-to-end biopharmaceutical development and manufacturing services. With deep expertise in cell line development, process optimization, and cGMP manufacturing, Northway Biotech supports programs from early-stage development through to commercial production. Founded in 2004, the privately held company operates state-of-the-art facilities in Lithuania and the United States, delivering high-quality, compliant solutions tailored to each client's unique needs. For further information, please visit Northway Biotech Contact: Prof. Vladas Algirdas BumelisCEO and Chairman of the AATec Medical Contact: Dr. Rüdiger Jankowsky, CEOinfo@ Media Contact: MC ServicesKatja Arnold, Julia von Hummelaatec-medical@ +49 (0)89 2102280 SOURCE: Northway Biotech press release
Globe and Mail
11-03-2025
- Business
- Globe and Mail
Non-Cystic Fibrosis Bronchiectasis Clinical Trials and Pipeline 2025: EMA, PDMA, FDA Approvals, Medication, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight
"Non-Cystic Fibrosis Bronchiectasis Pipeline" Non-Cystic Fibrosis Bronchiectasis companies in the treatment market are NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others. (Albany, USA) 'Non-Cystic Fibrosis Bronchiectasis Pipeline Insight, 2025' report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Non-Cystic Fibrosis Bronchiectasis Market. The Non-Cystic Fibrosis Bronchiectasis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details. As per DelveInsight's assessment, globally, Non-Cystic Fibrosis Bronchiectasis pipeline constitutes 16+ key companies continuously working towards developing 17+ Non-Cystic Fibrosis Bronchiectasis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. Some of the key takeaways from the Non-Cystic Fibrosis Bronchiectasis Pipeline Report: NCFB Companies across the globe are diligently working toward developing novel Non-Cystic Fibrosis Bronchiectasis treatment therapies with a considerable amount of success over the years. Non-Cystic Fibrosis Bronchiectasis companies working in the treatment market are NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others, are developing therapies for the Non-Cystic Fibrosis Bronchiectasis treatment. Emerging Non-Cystic Fibrosis Bronchiectasis therapies in the different phases of clinical trials are- NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others are expected to have a significant impact on the Non-Cystic Fibrosis Bronchiectasis market in the coming years. In February 2025, Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Brensocatib for patients with non-cystic fibrosis bronchiectasis. In October 2024, Insmed shared positive late-breaking subgroup data from the Phase III ASPEN study of brensocatib for patients with NCFB at the CHEST 2024 Annual Meeting. In July 2024, Armata Pharmaceuticals stated that it had completed enrollment in its Tailwind Phase 2 clinical trial of inhaled AP-PA02 in patients with NCFB and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. In May 2024, Insmed Incorporated reported encouraging topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate brensocatib's effectiveness, safety, and tolerability in patients with non-cystic fibrosis bronchiectasis. The study accomplished its primary aim, with both brensocatib dose strengths showing statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) compared to placebo. The study also met several of its predetermined secondary goals with statistical significance. In July 2023, Zambon, a global pharmaceutical company dedicated to innovating treatments and enhancing the health and well-being of patients, revealed the conclusive findings from the Phase 3 PROMIS-I and PROMIS-II studies. These results were unveiled during the 2023 6th World Bronchiectasis Conference held in New York, NY. In December 2022, Haisco Pharmaceutical Group Co., Ltd. has commenced a trial titled 'Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study.' This study aims to evaluate the effectiveness and safety of HSK31858 in individuals diagnosed with Non-cystic Fibrosis Bronchiectasis. In April 2022, The FDA awarded breakthrough therapy designation to colistimethate sodium powder intended for nebulization solution to alleviate pulmonary exacerbations in adults afflicted with Non-cystic fibrosis bronchiectasis and Pseudomonas aeruginosa. The basis for the FDA's breakthrough therapy designation was supported by findings from the phase III PROMIS-I study, showcasing that CMS I-neb notably decreased annual rates of pulmonary exacerbations compared to a placebo within this patient population. Non-Cystic Fibrosis Bronchiectasis Overview Non-Cystic Fibrosis Bronchiectasis (NCFBE) is a chronic lung condition characterized by permanent dilation and damage of the bronchi, leading to impaired mucus clearance and recurrent infections. Unlike cystic fibrosis-related bronchiectasis, NCFBE is caused by underlying conditions such as chronic infections, autoimmune diseases, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis (ABPA), or immune deficiencies. Patients with NCFBE experience persistent cough, excessive mucus production, recurrent respiratory infections, and shortness of breath, fatigue, and wheezing. The accumulation of mucus creates a breeding ground for bacteria, leading to frequent exacerbations and lung function decline. Common pathogens, including Pseudomonas aeruginosa and Haemophilus influenzae, contribute to disease progression and complications. Non-Cystic Fibrosis Bronchiectasis Diagnosis involves high-resolution computed tomography (HRCT) scans, pulmonary function tests, sputum cultures, and blood tests to identify underlying causes. Non-Cystic Fibrosis Bronchiectasis Treatment focuses on airway clearance therapies, bronchodilators, inhaled antibiotics, corticosteroids, and mucolytics to reduce symptoms and prevent exacerbations. Pulmonary rehabilitation, vaccination, and lifestyle modifications also play a crucial role in disease management. While NCFBE is a chronic and progressive condition, advancements in targeted therapies, biologics, and precision medicine are improving patient outcomes, reducing exacerbations, and enhancing quality of life. Emerging Non-Cystic Fibrosis Bronchiectasis Drugs Under Different Phases of Clinical Development Include: Non-Cystic Fibrosis Bronchiectasis Route of Administration Non-Cystic Fibrosis Bronchiectasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as Intravenous Subcutaneous Oral Intramuscular Non-Cystic Fibrosis Bronchiectasis Molecule Type Non-Cystic Fibrosis Bronchiectasis Products have been categorized under various Molecule types, such as Monoclonal antibody Small molecule Peptide Non-Cystic Fibrosis Bronchiectasis Pipeline Therapeutics Assessment Non-Cystic Fibrosis Bronchiectasis Assessment by Product Type Non-Cystic Fibrosis Bronchiectasis By Stage and Product Type Non-Cystic Fibrosis Bronchiectasis Assessment by Route of Administration Non-Cystic Fibrosis Bronchiectasis By Stage and Route of Administration Non-Cystic Fibrosis Bronchiectasis Assessment by Molecule Type Non-Cystic Fibrosis Bronchiectasis by Stage and Molecule Type DelveInsight's Non-Cystic Fibrosis Bronchiectasis Report covers around 17+ products under different phases of clinical development like Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Further Non-Cystic Fibrosis Bronchiectasis product details are provided in the report. Download the Non-Cystic Fibrosis Bronchiectasis pipeline report to learn more about the emerging Non-Cystic Fibrosis Bronchiectasis therapies @ Non-Cystic Fibrosis Bronchiectasis Treatment Market Some of the key companies in the Non-Cystic Fibrosis Bronchiectasis Therapeutics Market include: Key companies developing therapies for Non-Cystic Fibrosis Bronchiectasis are – Insmed Incorporated, AstraZeneca, Zambon, CSL Behring, Chiesi Farmaceutici, Haisco Pharmaceutical, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, SolAeroMed, and others. Non-Cystic Fibrosis Bronchiectasis Pipeline Analysis: The Non-Cystic Fibrosis Bronchiectasis pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Non-Cystic Fibrosis Bronchiectasis with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non-Cystic Fibrosis Bronchiectasis Treatment. Non-Cystic Fibrosis Bronchiectasis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Non-Cystic Fibrosis Bronchiectasis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Non-Cystic Fibrosis Bronchiectasis market. The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc. Download Sample PDF Report to know more about Non-Cystic Fibrosis Bronchiectasis drugs and therapies – Non-Cystic Fibrosis Bronchiectasis Clinical Trials and Advancements Non-Cystic Fibrosis Bronchiectasis Pipeline Market Drivers Recent Developments to Improve Research into Bronchiectasis, emergence of Novel Drugs & Therapies with Great Market Potential are some of the important factors that are fueling the Non-Cystic Fibrosis Bronchiectasis Market. Non-Cystic Fibrosis Bronchiectasis Pipeline Market Barriers However, challenges Associated with the Drug Delivery, regulatory & Economic Hindrance and other factors are creating obstacles in the Non-Cystic Fibrosis Bronchiectasis Market growth. Scope of Non-Cystic Fibrosis Bronchiectasis Pipeline Drug Insight Coverage: Global Key Non-Cystic Fibrosis Bronchiectasis Companies: NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others Key Non-Cystic Fibrosis Bronchiectasis Therapies: NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others Non-Cystic Fibrosis Bronchiectasis Therapeutic Assessment: Non-Cystic Fibrosis Bronchiectasis current marketed and Non-Cystic Fibrosis Bronchiectasis emerging therapies Non-Cystic Fibrosis Bronchiectasis Market Dynamics: Non-Cystic Fibrosis Bronchiectasis market drivers and Non-Cystic Fibrosis Bronchiectasis market barriers Table of Contents 1. Non-Cystic Fibrosis Bronchiectasis Report Introduction 2. Non-Cystic Fibrosis Bronchiectasis Executive Summary 3. Non-Cystic Fibrosis Bronchiectasis Overview 4. Non-Cystic Fibrosis Bronchiectasis- Analytical Perspective In-depth Commercial Assessment 5. Non-Cystic Fibrosis Bronchiectasis Pipeline Therapeutics 6. Non-Cystic Fibrosis Bronchiectasis Late Stage Products (Phase II/III) 7. Non-Cystic Fibrosis Bronchiectasis Mid Stage Products (Phase II) 8. Non-Cystic Fibrosis Bronchiectasis Early Stage Products (Phase I) 9. Non-Cystic Fibrosis Bronchiectasis Preclinical Stage Products 10. Non-Cystic Fibrosis Bronchiectasis Therapeutics Assessment 11. Non-Cystic Fibrosis Bronchiectasis Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Non-Cystic Fibrosis Bronchiectasis Key Companies 14. Non-Cystic Fibrosis Bronchiectasis Key Products 15. Non-Cystic Fibrosis Bronchiectasis Unmet Needs 16 . Non-Cystic Fibrosis Bronchiectasis Market Drivers and Barriers 17. Non-Cystic Fibrosis Bronchiectasis Future Perspectives and Conclusion 18. Non-Cystic Fibrosis Bronchiectasis Analyst Views 19. Appendix 20. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
