Absci announces first participants dosed in Phase 1/2a HEADLINE trial

Absci (ABSI) 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, pharmacodynamics, 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.”