Structure Therapeutics Announces Initiation of Phase 1 Clinical Study of Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity

SAN FRANCISCO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ:GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671, the company's lead oral small molecule amylin receptor agonist for the treatment of obesity. ACCG-2671 was designed via the company's next generation structure-based drug discovery platform to harness the established metabolic benefits of amylin biology in an oral, once-daily small molecule, with the potential to improve scalability, combinability, and patient access.

"We believe amylin-based therapies are poised to become an important next-generation component of the treatment landscape for obesity and related conditions. Powered by our differentiated GPCR structure-based drug discovery platform, we have efficiently advanced ACCG-2671 into the clinic as the industry's most advanced oral small molecule amylin therapy," said Xichen Lin, Ph.D., Chief Scientific Officer of Structure Therapeutics. "Our platform enables the design of highly selective, orally available GPCR-targeted medicines. Preclinical data of ACCG-2671 show potent target engagement, robust weight loss as a monotherapy and further weight loss when used in combination with a glucagon-like-peptide receptor agonist (GLP-1 RA), a favorable safety profile, and pharmacokinetics profile suitable for once-daily dosing. ACCG-2671 has the potential to serve as a differentiated backbone therapy, both as a monotherapy and in combination with other weight loss medicines."

The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of ACCG-2671 in both healthy volunteers and individuals with obesity. The study will include single-ascending dose and multiple-ascending dose cohorts.

"This has been a transformative year for Structure Therapeutics, marked by excellence in clinical execution and compelling validation of our oral small molecule approach to obesity and metabolic disease," said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. "Following the recent positive Phase 2 clinical data from our ACCESS program for aleniglipron, our once-daily oral small molecule GLP-1 receptor agonist, this initiation of our Phase 1 study of ACCG-2671 represents another major milestone and establishes the first clinical entry from our amylin portfolio. Together, these programs underscore the breadth and strength of our pipeline and our ability to translate proven metabolic biology into differentiated oral therapies that have the potential to broaden access and improve long-term treatment options for people living with obesity."

About ACCG-2671 and Structure's Amylin Portfolio

Amylin is co-secreted with insulin from pancreatic beta cells in response to nutrient ingestion. Amylin has important physiological effects including reducing appetite, increasing satiety, leptin sensitivity and energy expenditure. Preclinical data from current amylin-based treatments in development suggest a potential for amylin to reduce fat mass and preserve lean mass.

Two types of amylin-based treatments for the treatment of obesity are currently being developed: dual amylin and calcitonin receptor agonists (DACRAs) that target both the amylin and calcitonin receptors; and selective amylin receptor agonists (SARAs) that preferentially target the amylin receptor.

Structure Therapeutics is developing a series of both DACRAs and SARAs, as both approaches have demonstrated potential as obesity and chronic weight management treatment. Structure's lead amylin-based molecule, ACCG-2671, is a DACRA that is being evaluated for use either alone or in combination with GLP-1R agonists to treat obesity and associated diseases. Structure is also advancing ACCG-3535, a second DACRA with a unique chemical structure from ACCG-2671. Structure is also developing SARA molecules, which are currently in preclinical development.

About Structure Therapeutics

Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company's future plans and prospects; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of ACCG-2671 and aleniglipron; the design of the Phase 1 study of ACCG-2671; the belief that amylin-based therapies are poised to become an important next-generation component of the treatment landscape for obesity and related conditions; the potential for ACCG-2671 to serve as a differentiated backbone therapy, both as a monotherapy and in combination with other weight loss medicines; the Company's plans to develop a series of DACRAs and SARAs; the Company's ability to translate proven metabolic biology into differentiated oral medicines that have the potential to broaden access and improve long-term treatment options for people living with obesity; the potential of DACRAs and SARAs as obesity and chronic weight management treatment; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases "anticipated," "believe," "expect," "may," "on track," "plan," "potential," "suggests," "to be," "to begin," "will," and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company's forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company's planned clinical studies; the Company's ability to advance aleniglipron, ACCG-2671, ACCG-3535, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company's therapeutic candidates; competitive products or approaches limiting the commercial value of the Company's product candidates; the timing and results of preclinical and clinical studies; the Company's ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company's ability to protect its intellectual property; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's latest Quarterly Report on Form 10-Q and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investors:

Danielle Keatley

Structure Therapeutics Inc.

[email protected]

Media:

Dan Budwick

1AB

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