Absci (NASDAQ:ABSI) expects to release interim data from its experimental pattern hair loss treatment in December, followed by a fuller assessment in early 2027, executives said during the company’s third-quarter business update on November 12.
The company is also preparing a mid-2027 start for a Phase II trial of the same drug, ABS-201, in endometriosis. Absci ended September with $173.7 million in cash, cash equivalents and marketable securities and said it expects those resources to fund operations into the second half of 2028.
Hair loss trial approaches first readout
Chief Medical Officer and Head of R&D Ransi Somaratne said the randomized, double-blind, placebo-controlled HEADLINE trial continues to enroll and that emerging safety, pharmacokinetic and immunogenicity data have been encouraging. The study’s primary endpoints are safety and tolerability; secondary measures include hair count, hair width and pigmentation.
The planned 13-week update will focus on male pattern hair loss and include target area hair count, which measures non-vellus hairs at least 30 microns wide, along with hair width and total hair count. Total count also includes finer vellus hairs.
Founder and CEO Sean McClain said examining both types of hair was not a change in strategy. Management believes the broader measure could help assess the drug’s biological activity before the 26-week readout, including whether finer hairs might later become thicker. That potential has yet to be established in the trial.
Somaratne said the interim analysis is not designed to change how the trial is conducted. McClain said the December release would include all 13-week data from the 300-milligram group, a majority of the 600-milligram group and potentially a limited look at the 1,200-milligram group. Somaratne said safety results would be aggregated by dose group rather than separated by treatment and placebo, because the study remains ongoing.
Absci has also started enrolling two exploratory, open-label groups of women with pattern hair loss at doses of 300 and 1,200 milligrams. Somaratne said the doses were selected to explore the ends of the range, not because of efficacy results observed in men. The company plans to provide timing for those data later.
For the 26-week assessment, CFO and Chief Business Officer Zach Jonasson said consumer research supported a target area hair count increase of 30 to 35 non-vellus hairs per square centimeter as a commercially attractive result. He said the research tested a hypothetical product profile with convenient administration and durable efficacy; it was not a clinical result for ABS-201.
Endometriosis study planned for 2027
Absci is designing its global Phase II STORYLINE trial to assess ABS-201 in approximately 150 participants with surgically diagnosed endometriosis and moderate to severe associated pain, subject to finalizing the protocol and obtaining regulatory clearance.
The placebo-controlled, dose-ranging study is expected to test two or three dose levels. Planned efficacy measures include patient-reported reductions in menstrual pain and non-menstrual pelvic pain. Somaratne said safety and pharmacokinetic data from healthy female volunteers in HEADLINE will help inform dose selection.
McClain said Absci expects to provide more clarity early next year on the timing of endometriosis proof-of-concept data and whether it will conduct an interim analysis.
Spending rises as clinical work advances
Research and development expenses increased to $23.6 million in the third quarter from $19.2 million a year earlier, primarily because of work on internal programs, including external nonclinical and clinical development of ABS-201. Selling, general and administrative expenses rose to $9 million from $8.4 million, primarily due to stock-based compensation.
Cash, cash equivalents and marketable securities declined from $201.1 million at June 30 to $173.7 million at September 30. The company also named Gerry Muhle its first chief commercial officer as it begins building infrastructure for potential direct-to-consumer programs.
Beyond ABS-201, Absci is developing other prolactin receptor antibodies, including ABS-202, for additional indications. Executives said the early-stage pipeline also includes non-prolactin targets in areas such as metabolism, healthy aging and preventive care.
About Absci (NASDAQ:ABSI)
Absci Corporation is a biotechnology company that uses artificial intelligence and laboratory research to discover and develop biologic drugs. Its platform combines generative AI with experimental testing to design and evaluate potential drug candidates, including antibodies and other protein-based medicines. The company also works with pharmaceutical and biotechnology partners on drug discovery programs and advances its own pipeline of potential therapies. Its approach is intended to connect computational design with laboratory validation, helping assess whether designed molecules have useful properties.
