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Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990)
Newsfilterยท 2025-03-03 11:00
Core Insights - Apogee Therapeutics announced positive interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, demonstrating an approximately 60-day half-life, which exceeds trial objectives [1][2][3] - The company plans to initiate a Phase 1b head-to-head study of APG279 (APG777 + APG990) against DUPIXENT this year, with results expected in the second half of 2026 [1][4][7] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for atopic dermatitis, asthma, eosinophilic esophagitis, and chronic obstructive pulmonary disease [2][10] - The company aims to overcome limitations of existing therapies by targeting well-established mechanisms of action and optimizing antibody properties [10] Product Details - APG990 is a subcutaneous, half-life extended monoclonal antibody targeting OX40L, positioned upstream in the inflammatory pathway, allowing for broader inhibition of Type 1, Type 2, and Type 3 inflammation [4][9] - The pharmacokinetic data from the Phase 1 trial supports potential maintenance dosing every three to six months with as little as 50 mg, and a single 2 mL coformulated injection of APG279 could be administered two to four times per year [3][6] Clinical Trial Insights - The Phase 1 clinical trial was a double-blind, placebo-controlled study involving 40 healthy adult participants, evaluating the safety, tolerability, and pharmacokinetics of APG990 [5][6] - APG990 demonstrated good tolerability at doses up to 1,200 mg, with the most common treatment-emergent adverse event being headache, and no severe adverse events reported [6][7] Future Plans - Based on interim results, the company plans to submit an Investigational New Drug application for APG279 and initiate a Phase 1b clinical trial in moderate-to-severe atopic dermatitis against DUPIXENT in 2025 [7][8]