Absci(US:ABSI) Globenewswire·2025-12-04 13:00Core Insights - Absci Corporation has initiated a Phase 1/2a clinical trial for ABS-201, an investigational anti-prolactin receptor antibody, with interim data expected in the second half of 2026 [1][2][9] - The trial aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of ABS-201, targeting conditions such as androgenetic alopecia (AGA) and endometriosis [2][3][7] Company Overview - Absci Corporation is a clinical-stage biopharmaceutical company utilizing generative AI to develop innovative therapeutics [1][12] - The company is focused on creating a pipeline of differentiated assets, leveraging AI to identify high-value biological targets and streamline clinical development [3][12] Clinical Trial Details - The Phase 1/2a HEADLINE trial will enroll up to 227 healthy volunteers, assessing primary endpoints of safety and tolerability, with secondary endpoints including pharmacokinetics, pharmacodynamics, and efficacy measures [3][4][5] - The trial includes a single ascending dose (SAD) portion followed by a multiple ascending dose (MAD) portion, aimed at demonstrating proof-of-concept for hair regrowth in AGA [4][5] Market Opportunity - Androgenetic alopecia affects approximately 80 million Americans, with current FDA-approved treatments showing limited efficacy and significant side effects [8] - The company anticipates that ABS-201 could provide a novel treatment pathway for AGA and endometriosis, addressing significant unmet medical needs [3][11] Future Development Plans - Absci plans to initiate Phase 2 clinical development for endometriosis in Q4 2026, leveraging data from the AGA trial [7][11] - An interim readout from the Phase 2 trial in endometriosis is expected in the second half of 2027 [7][11]