Interim Trial Results for hair loss treatment dubbed ABS-201 shows positive results with mild side effects. Will now move on to Phase 2.

https://www.dermatologytimes.com/view/interim-trial-results-and-preclinical-data-highlight-potential-of-abs-201-in-androgenetic-alopecia

Single-ascending-dose IV ABS-201 (150–1800 mg) in 32 volunteers produced no SAEs; TEAEs were predominantly mild, with headache most frequent.

Pharmacokinetics suggested a ≥65-day half-life, enabling infrequent administration (2–3 doses per 6 months) and showing no apparent ADA-driven exposure changes.

Absci's ABS-201 posts early phase 1 safety and long half-life, while new data show prolactin-receptor blockade may revive hair growth in AGA.

The investigational antibody ABS-201 showed a favorable preliminary safety profile and pharmacokinetic characteristics in the single-ascending-dose portion of a first-in-human phase 1/2a trial, while preclinical poster data provide additional support for its proposed mechanism in androgenetic alopecia (AGA).1 The findings were reported by Absci alongside interim clinical data from the ongoing HEADLINE trial (NCT07317544).2

“We are particularly encouraged by the emerging safety, pharmacokinetic, and immunogenicity profile observed to date," Ransi Somaratne, MD, Chief Medical Officer of Absci, said in the press release. "We look forward to further characterizing ABS-201’s clinical profile and potential in the ongoing MAD portion of the HEADLINE trial for AGA, and to initiating a phase 2 trial for endometriosis later this year.”1

Infrequent Dosing and Tolerability Findings The randomized, double-blind, placebo-controlled phase 1 study enrolled 32 healthy adults across 4 single-ascending-dose cohorts. Participants received 150, 450, 900, or 1800 mg of ABS-201 or matched placebo intravenously, with a 3:1 randomization within each cohort. Blinded interim safety data through June 8, 2026, showed no serious adverse events. Treatment-emergent adverse events were generally mild, with one moderate event (a headache in the 900-mg cohort) that was considered unlikely to be related to treatment. Treatment-related adverse events occurred in 5 participants and were all mild. Headache was the most frequently reported adverse event, occurring in 4 patients.

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Interim pharmacokinetic data indicated an estimated half-life of at least 65 days, although continued follow-up is needed to confirm the duration. The pharmacokinetic profile supports the possibility of dosing 2 or 3 times over a 6-month period. No apparent effect of treatment-emergent anti-drug antibodies on pharmacokinetics was observed in the single-dose cohorts. Based on review of the blinded safety and pharmacokinetic data, the trial has progressed to its multiple-ascending-dose portion, in which participants with AGA are receiving subcutaneous ABS-201.