Phase 2 trial to assess efficacy and safety in participants with surgically-diagnosed endometriosis and moderate to severe endometriosis-associated pain (EAP)

Anticipated initiation of Phase 2 trial in mid-2027

VANCOUVER, Wash. and NEW YORK, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ:ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today announced additional details for the company’s planned global, multi-center Phase 2 STORYLINE clinical trial evaluating ABS-201, an investigational anti-prolactin receptor (PRLR) antibody engineered with Absci’s generative AI platform, for endometriosis.

The planned Phase 2, double-blind, randomized, placebo-controlled trial would assess efficacy and safety in participants with surgically-diagnosed endometriosis and moderate to severe endometriosis-associated pain (EAP) after a run-in period. Efficacy endpoints would include reductions in dysmenorrhea and non-menstrual pelvic pain as reported via patient-reported measures. For this trial, Absci anticipates recruiting approximately 150 patients from approximately 10 or more countries, subject to protocol finalization and regulatory clearance.

"Endometriosis affects roughly one in ten women of reproductive age, often leading to debilitating and life-altering pain. We are developing ABS-201 because we believe prolactin receptor blockade offers a fundamentally different, non-hormonal approach that may fulfill the substantial unmet clinical need facing these patients," said Ransi Somaratne, MD, Chief Medical Officer, Head of R&D. "The initiation of this Phase 2 trial would be an important step toward establishing ABS-201’s ability to deliver durable relief of endometriosis-associated pain with a differentiated safety and tolerability profile."

With the safety, tolerability, and pharmacokinetic (PK) data being generated for ABS-201 in the company’s ongoing HEADLINE™ trial, Absci anticipates initiation of this Phase 2 clinical trial for endometriosis in mid-2027. Absci is designing STORYLINE as a dose-ranging trial, anticipating testing two or three dose levels that will be confirmed following review of HEADLINE data.

About Absci

Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci’s approach leverages a continuous feedback loop between advanced AI algorithms and wet lab validation. Each cycle refines our data and strengthens our models, facilitating rapid innovation and enhancing the precision of our therapeutic designs. Alongside collaborations with top pharmaceutical, biotech, tech, and academic leaders, Absci is advancing its own pipeline of AI designed therapeutics including ABS-201™, a groundbreaking innovation in hair regrowth with the potential to redefine treatment possibilities for pattern hair loss. ABS-201 is also being investigated as a potential "best-in-class" therapeutic for endometriosis, a condition with significant unmet medical need and market potential. Absci is headquartered in Vancouver, WA, with AI Research Labs in New York City and Serbia, and an Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding any or all of the following: the development and clinical progress of Absci's pipeline programs, including ABS-201; the design, enrollment, conduct, and timelines of our ongoing Phase 1/2a HEADLINE™ clinical trial of ABS-201 for pattern hair loss and the data being generated therefrom; the anticipated use of safety, tolerability, and pharmacokinetic data from the HEADLINE trial to inform dose selection for the STORYLINE™ clinical trial, including the anticipated testing of two or three dose levels pending review of such data; the planned design, patient enrollment targets, dosing strategy, country participation, and efficacy and safety endpoints of the Phase 2 STORYLINE trial of ABS-201 for endometriosis; the anticipated initiation of the STORYLINE trial in mid-2027, subject to regulatory clearance and protocol finalization; the potential for ABS-201 to provide efficacy in reducing endometriosis-associated pain and a differentiated safety and tolerability profile; the potential advancement of ABS-201 into Phase 3 development; the anticipated characteristics and product profile of ABS-201 as a drug product and its ability to fulfill unmet clinical need in endometriosis; and potential market opportunity and commercial prospects for ABS-201. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading "Risk Factors" in Absci Corporation's most recent annual report on Form 10-K and in any subsequent filings made by Absci Corporation with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Absci® standard character mark, ABS-201™, STORYLINE™, HEADLINE™, and Integrated Drug Creation™ are trademarks and registered trademarks of Absci Corporation.

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