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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of
About this update from Apogee Therapeutics, Inc.
[{"type":"text","content":"Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 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), eosinophilic esophagitis (EoE) and other I&I indications, today announced that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions. “The initiation of the APG333 Phase 1 clinical trial marks our fourth program to enter clinical trials in less than 18 months and represents an important step in our pipeline evolution, as we continue to establish the building blocks for our combination strategy,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “TSLP is a clinically validated target that plays an important role in both Type 2 and Type 3 inflammation, the primary drivers of inflammatory respiratory conditions. Based on its mechanism, it has the potential to broadly address obstructive respiratory diseases, including for the approximately half of patients with low Type 2 inflammatory respiratory diseases who currently have fewer treatment options. We plan to initially explore APG333 for the treatment of asthma, with the ultimate goal of leveraging this investigational therapy in combination with APG777, a combination approach that could optimally address respiratory and broader I&I diseases.” The APG333 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 APG333 and is expected to enroll appr...