Absci (NASDAQ:ABSI) Founder and Chief Executive Officer Sean McClain said the company is nearing a key clinical inflection point as it advances AI-designed drug candidate ABS-201 into studies for androgenic alopecia and endometriosis.
Speaking during a company event, McClain described Absci as a “generative AI drug creation company” that began 15 years ago with a focus on scaling technology to study protein-protein interactions. He said the company became an early adopter of generative AI in 2018 and has since used the technology to pursue difficult drug targets, including GPCRs and ion channels.
AI Platform and Pipeline Strategy
McClain said Absci’s approach is aimed at “industrializing” drug discovery by increasing the number of development opportunities while reducing cost and time. He said the company has been able to move drug candidates toward the clinic with roughly $10 million to $15 million of investment, compared with what he described as more than $50 million traditionally.
He also highlighted Absci’s AI platform work, including Origin-1, which he said was used to target “zero prior epitopes,” or epitopes with no known structural information or antibody complex. McClain said Absci believes it is the first group to show that capability and noted that the company recently released an updated manuscript on the work.
In addition to its internal pipeline, McClain referenced past and ongoing partnerships with pharmaceutical companies including Merck, AstraZeneca and Almirall. He said that in the Almirall collaboration, Absci used its Origin 2 technology to drug an ion channel that had been known for about 20 years but had not previously been successfully targeted.
ABS-201 in Androgenic Alopecia
McClain said ABS-201 is currently in a Phase 2 clinical study for androgenic alopecia, a form of pattern hair loss affecting both men and women. He said the condition affects about 80 million Americans and that treatment innovation in the space has been limited, citing the continued use of therapies targeting the androgen receptor, finasteride and minoxidil.
According to McClain, Absci’s research suggests prolactin may contribute to inflammatory and fibrotic processes in the scalp, pushing hair follicles into the catagen phase and contributing to follicle miniaturization. He said blocking the prolactin receptor may reverse miniaturization and help rebuild the stem cell niche.
McClain cited preclinical work in mice showing ABS-201 produced stronger hair regrowth than topical minoxidil 5% and oral minoxidil in a shaving study. He also discussed earlier work in stump-tailed macaques conducted by Andreas Busch, Absci’s former chief innovation officer, while at Bayer. McClain said the animals, which naturally go bald, regrew hair after treatment with an anti-prolactin receptor antibody, regained pigmentation and continued to regrow hair for four years after treatment ended.
Absci also presented new data from premenopausal female scalp biopsies. McClain said the results were similar to what the company previously observed in male samples, with ABS-201 increasing the anagen phase and prolactin pushing follicles toward the catagen phase. He said postmenopausal female data are still ongoing and will be shared when available.
Clinical Timeline and Market Estimates
McClain said Absci has completed the single ascending dose portion of the ABS-201 study and plans to release safety, tolerability and pharmacokinetic data “within a very short amount of time.” He said the multiple ascending dose portion has started in healthy individuals with androgenic alopecia.
The company expects a 13-week interim readout later this year and a 26-week efficacy readout in the first part of 2027, McClain said. Based on a consumer quantitative study assuming oral minoxidil-like efficacy and durability of two to three years, McClain said Absci estimates the U.S. market opportunity for ABS-201 in androgenic alopecia at $25 billion and the global opportunity at $40 billion.
Endometriosis Program
McClain said Absci also plans to study ABS-201 in endometriosis, with a study expected to start at the end of the year and a Phase 2 readout expected next year. He described endometriosis as a disease affecting one in 10 women and said current standards of care are poor.
McClain said prolactin appears to be involved in lesion formation and pain sensitization. He cited preclinical mouse data showing that blocking the prolactin receptor reduced overall pain, measured by how far mice could walk, and said the mechanism may have potential to reduce both lesion pain and lesion size. He estimated the endometriosis market opportunity at more than $4.5 billion.
McClain closed by reiterating that Absci expects upcoming ABS-201 data, including single ascending dose safety, tolerability and pharmacokinetic results, followed by Phase 2 readouts in androgenic alopecia and endometriosis over the next 24 months.
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.
