Absci (NASDAQ:ABSI) founder and CEO Sean McClain outlined the company’s AI-driven drug development strategy and its prolactin receptor-focused pipeline during a presentation at the Jefferies New York Global Healthcare Conference.
McClain described Absci as an “AI drug creation company” using an AI-native platform designed to shorten the time and reduce the cost required to move new medicines into clinical testing. He said traditional drug development can require $50 million to $100 million and five to six years to bring one drug into the clinic, while Absci has shown with its programs that it can reach the clinic in roughly 24 months with an investment of about $10 million to $15 million.
AI Platform and Partner Work
He said Absci is focused on using AI to develop differentiated assets against modalities and targets that have historically been difficult to drug, including ion channels and GPCRs. As an example, McClain cited the company’s work with Almirall, saying Absci showed it could drug an ion channel that had been known for 30 years but had not previously been successfully drugged.
McClain also discussed Origin-1, which he described as a state-of-the-art antibody design model. He said the model demonstrated the ability to target “zero-prior epitopes,” or targets with no known binders or structurally known binders to that epitope.
ABS-201 in Hair Regrowth
A major focus of the presentation was ABS-201, an anti-prolactin receptor antibody being studied for androgenetic alopecia, or hair loss. McClain said 80 million men and women in the U.S. suffer from androgenetic alopecia and argued that current standards of care, including minoxidil and finasteride, have not changed significantly in decades.
McClain said Absci believes prolactin builds up on the scalp over time and can push hair follicles from the active growth, or anagen, state into the catagen state associated with miniaturization. By blocking the prolactin receptor, he said, ABS-201 is intended to return follicles to the anagen state and convert vellus hairs into terminal hair growth.
He cited preclinical work in mice showing superior hair regrowth with ABS-201 compared with 5% oral minoxidil. He also discussed a stump-tailed macaque study conducted before Absci’s involvement, in which animals treated with an anti-prolactin receptor antibody regrew hair after six months and continued to regrow hair after treatment ended. McClain said Absci believes this may reflect a regenerative effect involving rebuilding the stem cell niche.
McClain also described a 72-hour ex vivo human punch biopsy study conducted with Professor Ralf Paus. He said ABS-201 drove follicles into the anagen state, while prolactin drove follicles toward catagen, and ABS-201 was able to rescue follicles when prolactin was added. He said the study also showed effects on K15 stem cells, collagen XVII and growth factors including FGF7 and IGF-1.
Clinical Timeline for Androgenetic Alopecia
Absci has started a phase I/II-A study of ABS-201. McClain said the single ascending dose portion enrolled non-androgenetic alopecia patients across doses from 150 mg to 1,800 mg. He said the company has seen a favorable safety and pharmacokinetic profile so far and expects to disclose initial safety and PK data in June.
The company has also started the multiple ascending dose portion in healthy volunteers with androgenetic alopecia. McClain said the subcutaneous dosing study includes 300 mg, 600 mg and 1,200 mg doses administered every eight weeks. A 13-week interim readout is expected in the second half of the year, with the full 26-week readout expected early next year.
The primary endpoint is safety and tolerability, while secondary measures include total area hair count, thickness and darkening. McClain said the 13-week analysis will remain blinded and will be used as a directional responder analysis.
Endometriosis Opportunity
McClain also discussed endometriosis as a second indication tied to prolactin receptor biology. He said one in 10 women suffer from the condition, which he described as painful, inflammatory and underserved by current standards of care.
According to McClain, Absci believes high levels of prolactin in endometrial tissue drive inflammation, lesion formation and pain sensitization. He said publicly available data and Absci’s preclinical work in mice suggest prolactin may contribute to both lesion formation and dysmenorrhea-related pain sensitization.
McClain said Absci sees a market opportunity for endometriosis of more than $4.5 billion and expects to begin a phase II study at the end of this year.
Upcoming Milestones
-
Initial safety and pharmacokinetic data from the single ascending dose portion of the ABS-201 phase I/II-A study are expected in June.
-
A 13-week interim readout in androgenetic alopecia is expected in the second half of the year.
-
A phase II endometriosis study is expected to start at the end of the year.
-
The full 26-week androgenetic alopecia readout is expected early next year.
McClain said Absci sees the value of its platform in the clinical assets it can produce, rather than the technology alone, and said the next 24 months are expected to include multiple clinical readouts.
About Absci (NASDAQ:ABSI)
Absci Corporation (NASDAQ: ABSI) is a biotechnology company that applies machine learning, synthetic biology and automation to accelerate the discovery and development of protein-based therapeutics. The company’s Integrated Drug Creation® (IDC®) platform is designed to identify and produce novel antibody and enzyme candidates at speeds and scales that traditional biopharma discovery methods cannot match. Absci works with pharmaceutical and biotechnology partners to generate, screen and optimize protein molecules for a wide range of therapeutic applications.
The core of Absci’s offering is its end-to-end discovery engine, which combines proprietary algorithms, high-throughput laboratory automation and a deep learning framework.
