Dupilumab

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

Apogee Therapeutics on Monday reported positive Phase II data for its long-acting therapy APG777 in patients with moderate-to-severe atopic dermatitis, setting up late-stage studies of the anti-IL-13 antibody next year. The news sent the company's shares up nearly 20%.The 16-week results come from Part A of the APEX trial, which included 123 adults with moderate-to-severe atopic dermatitis who were randomised to receive APG777 versus placebo. Participants in the APG777 arm were treated with an induction regimen dosing of 720 mg at weeks zero and two, followed by 360 mg at weeks four and 12. The primary endpoint of the study is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at week 16. Apogee noted that patients that benefited from treatment with APG777 continued maintenance dosing, evaluating 3- or 6-month dosing.Top-line results showed that the trial met its main goal, with APG777 demonstrating a significantly greater mean percent change from baseline at week 16 with an EASI reduction of 71.0% compared to placebo of 33.8%. Meanwhile, 66.9% of those treated with APG777 achieved EASI-75 compared to 24.6% on placebo."APG777 demonstrated the highest EASI-75 response rate both on a top-line 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, Apogee's CEO.Part B of the trial is testing higher exposures of APG777, with results expected in mid-2026, while a separate study is exploring the drug in combination with Apogee's OX40L inhibitor APG990 head-to-head versus Sanofi and Regeneron's Dupixent (dupilumab).