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ABSI Stock Up on Initiating Dosing in Androgenetic Alopecia Study
ZACKS· 2025-12-05 16:41
Core Insights - Absci Corporation (ABSI) shares increased by 13.4% following the initiation of dosing in a study for ABS-201, an investigational candidate for androgenetic alopecia (AGA) [1][6] - The company is leveraging its generative AI platform to develop ABS-201, a novel anti-PRLR antibody [1][10] Study Overview - The phase I/IIa HEADLINE study will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ABS-201 in AGA patients, with interim data expected in the second half of 2026 [2][6] - The study will involve up to 227 healthy volunteers, both with and without AGA, focusing on safety and tolerability as primary endpoints, while secondary endpoints will include PK, PD, immunogenicity, and early efficacy indicators [3][4] Study Design - The HEADLINE study consists of a single-ascending-dose (SAD) stage followed by a multiple-ascending-dose (MAD) stage, aimed at demonstrating human proof-of-concept for ABS-201 in treating AGA [4][6] - If positive results are obtained from the MAD phase, the program may advance to accelerated registrational development, positioning ABS-201 as a potential new treatment option for AGA [5][6] Market Potential - AGA affects approximately 80 million people in the U.S., while endometriosis impacts an estimated 5-10% of women of reproductive age, representing significant unmet medical needs in both conditions [9][10] - Absci Corporation is also expanding ABS-201's development to include endometriosis, with plans to initiate phase II clinical development in Q4 2026 [8][10] Competitive Landscape - Current treatment options for AGA and endometriosis often have limited efficacy or significant side effects, positioning ABS-201 as a potentially safer and more effective alternative [10]