Press release
Absci Announces First Participants Dosed in Phase 1/2a HEADLINE™ Trial of AI-Designed Antibody ABS-201™ for Androgenetic Alopecia
Study to evaluate safety and efficacy of novel anti-PRLR antibody; interim data anticipated in the second half of 2026 Trial design leverages operational
About this update from Absci Corporation
[{"type":"text","content":"Study to evaluate safety and efficacy of novel anti-PRLR antibody; interim data anticipated in the second half of 2026 Trial design leverages operational synergies to enable accelerated registrational trials for androgenetic alopecia (AGA) and Phase 2 for endometriosis KOL seminar scheduled for December 11 to discuss new human ex vivo data, clinical trial design, and market opportunity in AGA VANCOUVER, Wash. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative AI, today announced that the first healthy volunteers have been dosed in the Phase 1/2a HEADLINE study evaluating ABS-201, an investigational anti-prolactin receptor (PRLR) antibody engineered with Absci’s generative AI platform. The Phase 1/2a clinical trial will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ABS-201. Interim data are expected in the second half of 2026. “This milestone represents a truly exciting and transformative leap forward for regenerative biology. By advancing ABS-201 into the clinic, we are executing on our strategy to deliver a pipeline of differentiated assets,” said Sean McClain, Founder & CEO. “We believe this program highlights the massive leverage in our business model: using our AI engine to unlock high-value biological targets like PRLR, and then efficiently navigating clinical development to address significant unmet needs in both dermatology and women’s health.” “Current treatments for androgenetic alopecia and endometriosis are often characterized by limited efficacy and significant side effects. As prolactin has been demonstrated to be a key driver for both hair loss and endometriosis, this offers us a novel pathway for treatment for these patients,” said Andreas Busch, PhD, Chief Innovation Officer at Absci. “ABS-201 represents a potential best-in-class approach, targeting the prolactin receptor with a highly specific antibody designed for superior durability and potency. We are eager to evaluate how this novel mechanism translates in the clinic, with the goal of providing a safe, effective, long-lasting solution for millions of patients who have been underserved by the standard of care for decades.” The Phase 1/2a HEADLINE trial in AGA is a randomi...