ABS-201 - (HEADLINE)

June 24, 2026: Absci Corporation (NASDAQ: ABSI) reported positive interim Phase 1 data from its first-in-human HEADLINE trial (NCT07317544) of ABS-201, an investigational anti-prolactin receptor (PRLR) antibody being developed for androgenetic alopecia (AGA). As of the June 8, 2026 cutoff, blinded single ascending dose (SAD) data from 32 healthy participants across four IV dose cohorts (150, 450, 900, 1800 mg; 3:1 active:placebo) showed the study drug was generally well tolerated with no serious adverse events; most TEAEs were mild, with one moderate headache (assessed unlikely related). Treatment-related TEAEs occurred in 5 participants and were mild; headache was the most common TEAE (4 participants).

Interim pharmacokinetics suggest an estimated half-life of at least 65 days, supporting potential dosing of two or three injections over six months (pending confirmation). No apparent impact of anti-drug antibodies on PK was observed.

Based on SAD review, the study has progressed to the subcutaneous multiple ascending dose (MAD) portion in AGA participants (300, 600, 1200 mg SC). Absci expects interim proof-of-concept data in 2H 2026 and full proof-of-concept data in early 2027, and plans to initiate a Phase 2 trial in endometriosis later in 2026.