Absci Corporation has secured $100m in an underwritten offering while reporting positive first-in-human (FIH) data for its lead candidate ABS-201, leaving the biopharma company poised to push the drug’s clinical development programme forward in two indications.
By selling 13,495,277 of its shares at $7.41 per unit to prominent bidders like Eli Lilly and BVF Partners, the company is looking to advance the development of ABS-201, its artificial intelligence (AI)-designed anti-prolactin receptor (PRLR) antibody in both pattern hair loss and endometriosis.
With this cash in hand, Absci’s CMO, Ransi Somaratne, told Pharmaceutical Technology that the company will focus on ABS-201 in endometriosis first, as it plans to initiate a global Phase II study on the drug by the end of 2026.
Looking ahead to 2027, Absci is hoping to leapfrog ABS-201 to Phase III in male pattern hair loss based on the dose-ranging data it is currently collecting in the Phase I HEADLINE trial (NCT07317544) – though this will depend on interactions with the US Food and Drug Administration (FDA). If things pan out as expected, Absci plans to initiate two global Phase III studies with ABS-201 in men with pattern hair loss late into 2027.
Phase I data touts promising early signals
Absci’s raise comes parallel to its FIH win with ABS-201 in the ongoing HEADLINE study, in which the therapy was well tolerated and safe amongst participants with or without pattern hair loss.
Within the trial, researchers reported that a majority of the treatment-emergent adverse events (TEAEs) experienced by participants were mild in severity, with four moderate cases of headache observed, all which of which Absci noted are unlikely to be related to ABS-201’s mechanism of action (MoA). No patients experienced TEAEs linked to treatment with ABS-201 up to the cutoff date.
Somaratne noted that the drug’s early safety profile could also place it in a favourable position compared with other treatment options in endometriosis, as the approved therapies in this condition commonly cause menopause-like side effects. This means that individuals taking these drugs can experience hot flashes, bone demineralisation and potential metabolic profile changes – effects that have not shown up in the early data for ABS-201.
Data from the trial also suggests that ABS-201 has an estimated half-life of “at least 65 days,” which means that patients with hair loss could potentially receive two or three injections over a six-month period and see long-lasting impacts – differing significantly from potentially burdensome treatment with oral minoxidil or finasteride, which both require daily dosing and often stop working once a patient ceases treatment, Wen Sha, Absci's CVP Strategy & Business Operations tells Pharmaceutical Technology.
“The key distinction of this mechanism in pattern hair loss, if approved, is that it would be the first durable mechanism of hair regrowth,” Sha commented.
Sha bases this claim on the results of a Bayer study conducted on primates, which found that a strong proportion of stump-tailed macaques with pattern baldness given an anti-PRLR antibody experienced the reinstation of hair growth for four years following treatment.
“If our mechanistic hypothesis and what we see in monkeys holds true, this could be a ‘set it and forget it’ treatment option for patients over many years, instead of having to use a daily topical or oral treatment,” Sha explained.
The anti-PRLR’s mechanism wide-spanning potential
Alongside its efforts to explore ABS-201’s potential in endometriosis and pattern hair loss, Absci is also “casting a broad net” in the search for the drug’s promise in other indications.
“The more we look, the more we see prolactin playing a key role in disease processes beyond hair loss and endometriosis,” Somaratne said.
As prolactin appears to heighten pain sensitivity in female mammals, Somaratne explained that the drug could also play a key role in autoimmune and inflammatory diseases where women are generally more impacted than men, though he did not share any concrete plans on which specific indications Absci intends to pursue as it continues to develop ABS-201.
Currently, Chinese pharma company, Hope Medicine is also developing an anti-PRLR medicine for endometriosis and pattern hair loss; the same drug that demonstrated positive outcomes in the study involving stump-tailed macaques. Dubbed HMI-115, the drug is currently in two Chinese studies, including a Phase IIb/III trial for male pattern hair loss and a Phase III study in endometriosis. Swedish biotech BioInvent originally developed HMI-115 through a collaboration with Bayer, after which the latter company sold the drug's rights to Hope Medicine in 2019.
