Dupilumab

The Lung Association is expanding access to the free Lung Health Navigator program. A who’s who of respiratory disease drug developers has backed the American Lung Association’s push to help chronic obstructive pulmonary disease (COPD) patients in rural communities. Sanofi and Regeneron, AstraZeneca, Roche’s Genentech and GSK have provided support for the Living Well with COPD educational campaign. The support will equip the Lung Association to work with rural partners and referral networks, plus local healthcare providers, to deliver services and education to COPD patients.The Lung Association created the campaign for all families across the U.S. affected by COPD, but has paid particular attention to people in rural communities. COPD rates are higher in rural communities than urban areas, the nonprofit said, and patients may lack easy access to hospitals and other resources.  To address the health equity challenge, the Lung Association is expanding access to the free Lung Health Navigator program. The program connects COPD patients to licensed healthcare professionals, either via a phone call, online chat or video meeting. Patients receive free, one-to-one support.  The Lung Association said it is sharing educational materials to help patients “improve communication with their healthcare provider, better understand available COPD treatments and improve their quality of life.” In parallel, the nonprofit is supporting healthcare providers to improve awareness of COPD therapy options.All of the companies that supported the campaign have COPD therapies. Sanofi and Regeneron received FDA approval for Dupixent in the indication last year. The COPD launch got off to a promising start, but the companies’ IL-33 prospect suffered a phase 3 blow in May. Genentech also has an IL-33 candidate. AstraZeneca’s rival IL-33 prospect failed a phase 2 trial last year but development is continuing.AstraZeneca already sells Breztri Aerosphere, an inhaler that competes with GSK’s Trelegy Ellipta for the COPD market. GSK recently won FDA approval for its IL-5 antibody Nucala in COPD. Nucala became the third biologic approved in COPD after Dupixent and Verona Pharma’s Ohtuvayre. Merck & Co. is reportedly closing in on a $10 billion deal to buy Verona. 

APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including 71.0% decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposures with readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 APEX Part A testing potentially best in class 3- or 6-month maintenance dosing with 52-week readout anticipated 1H 2026 APG777 was well tolerated with a favorable safety profile consistent with other agents in class First patient dosed in APG279 (IL-13 + OX40L) Phase 1b head-to-head trial versus DUPIXENT with readout expected in 2H 2026 Management will host a conference call today at 8:00 a.m. ET SAN FRANCISCO, CA and BOSTON, MA, USA I July 07, 2025 I Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). “With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 demonstrated the highest EASI-75 response rate both on a topline and placebo-adjusted basis for any biologic in a global study to date, reinforcing its potential best-in-class profile for patients with moderate-to-severe atopic dermatitis,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing — benefitting patients, providers, and payers. Today’s results bring us closer to that vision, and we believe further de-risks APG777’s path to approval. In addition, I am excited for our two upcoming readouts to potentially even further improve on efficacy results — the accelerated APEX Part B testing higher exposures that is now expected to readout mid-2026, and the ongoing APG279 (IL-13 + OX40L) head-to-head trial against DUPIXENT expected to readout in the second half of 2026.” “Today’s results from APEX Part A demonstrate strong efficacy results across all key endpoints,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B. Combined with a favorable safety profile, these findings reinforce APG777’s potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents. On behalf of the entire Apogee team, I’d like to extend our gratitude to the patients and physicians for their support in the successful execution of this important trial.” APEX Phase 2 Part A Key 16-Week Results The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12. Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777. The primary endpoint of Part A is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16. Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1 and Itch Numeric Rating Scale (NRS) at Week 16. Initial 16-week findings from APEX Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class: “The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period,” said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. “Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee’s studies that are bringing this therapy closer to patients.” APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026. Webcast Details Apogee Therapeutics’ live webcast of the Phase 2 APEX Part A results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events . A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE) 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 https://apogeetherapeutics.com . SOURCE: Apogee Therapeutics