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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990
About this update from Apogee Therapeutics, Inc.
[{"type":"text","content":"Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases SAN FRANCISCO and WALTHAM, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting OX40L, which is being developed initially as a treatment for people living with AD. “The early initiation of the APG990 Phase 1 clinical trial marks another significant milestone for Apogee as we continue to focus on excellence in execution. We have advanced three of our programs into clinical trials in just 12 months, bringing potentially differentiated treatments closer to patients living with the largest I&I diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We are initially exploring APG990 for AD, and we believe combining two of the most active, orthogonal mechanisms of IL-13 (APG777) with OX40L (APG990) has the potential to expand patient reach with best-in-class efficacy and dosing. This approach underscores our relentless pursuit for the next wave of innovation in treating patients with AD. We refuse to stop at ‘good enough.’” The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG990 and is expected to enroll approximately 40 healthy adults into 5 cohorts. Apogee expects interim data from the trial in 2025. Pending positive results from the Phase 1 clinical trial and following submission of an Investigational New Drug application or foreign equivalent, the company plans to initiate a Phase 1 clinical trial of APG777 and APG990 as a potential first...