Structure Therapeutics, Inc.

Preclinical studies with ACCG-2671 demonstrate potent target engagement, robust weight loss, favorable safety profile and PK properties supportive of once-daily dosing in humans ACCG-2671 is the most advanced oral small molecule amylin-based drug candidate, with Phase 1 study initiation expected by year end 2025 Company to host conference call today at 4:30 p.m. Eastern Time Dec. 17, 2024 -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, today announced the selection of its lead oral small molecule amylin receptor agonist, ACCG-2671. Amylin is a hormone that plays an important role in regulating glycemia and energy balance and is recognized as a promising therapeutic target for obesity and related diseases due to its effects on reducing food intake and slowing the rate of gastric emptying. ACCG-2671 was designed as an oral small molecule Dual Amylin and Calcitonin Receptor Agonist (DACRA) and is expected to enter Phase 1 clinical development by year end 2025. “We believe amylin-based therapies are an important next-generation component of the treatment landscape for obesity and related conditions due to their potential for significant weight loss, favorable tolerability profile, and lean muscle mass preservation,” said Raymond Stevens, Ph.D., Founder and Chief Executive Officer of Structure Therapeutics. “As an oral small molecule, we envision ACCG-2671 as an additional backbone therapy to improve scalability, combinability and ultimately expand patient access to amylin-based weight loss medicines. We are in a unique position to have a potentially best in class GLP-1 oral small molecule with GSBR-1290 and now the most advanced amylin oral small molecule, both intended for use as monotherapies and as backbones for fixed dose oral combinations.” In preclinical studies, ACCG-2671 demonstrated potent and balanced in vitro activities toward the key amylin receptor and the calcitonin receptor. ACCG-2671 also further demonstrated robust in vivo efficacy and a pharmacokinetic (PK) and safety profile supporting once-daily oral dosing in humans. “The preclinical data demonstrate cagrilintide-like efficacy with an oral small molecule profile, underscoring ACCG-2671’s potential as a meaningfully differentiated oral treatment for obesity and related conditions,” said Xichen Lin, Ph.D., Chief Scientific Officer of Structure Therapeutics. “Our proven GPCR structure-based drug discovery platform enabled us to rapidly advance ACCG-2671 as the lead amylin receptor agonist. We are now developing a series of amylin-based drug candidates using our technology platform to maintain our leadership in this exciting space.” Structure Therapeutics will host a conference call and webcast today, December 17, 2024 at 4:30 p.m. Eastern Time. A live webcast of the call will be available on the Investor Relations page of Structure Therapeutics’ website at https://ir.structuretx.com/events-presentations/events. To access the call by phone, participants can use the dial-in numbers listed below: US-based Investors: 1-844-826-3033 International Investors: 1-412-317-5185 Conference Call ID: 10195088 The webcast will be made available for replay on Structure Therapeutics’ website beginning approximately two hours after the live event. The replay of the webcast will be available for 90 days. 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. ACCG-2671 is the first disclosed oral small molecule amylin-based development candidate, with Phase 1 study initiation expected by year end 2025. Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, Structure Therapeutics has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. The content above comes from the network. if any infringement, please contact us to modify.

Dive Brief:Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh Pharma $112 million for rights outside China to a preclinical pill that works similarly to the popular injection Wegovy.Per deal terms, China-based Hansoh could receive up to $1.9 billion in additional payouts based on reaching clinical, regulatory and commercial milestones. Hansoh has an option to co-promote or solely commercialize the pill, code-named HS-10535, in China.Merck was one of the few big U.S. drugmakers that didnt have an experimental obesity drug in development, and investors were therefore closely watching whether it would make a deal. Choosing a relatively inexpensive licensing deal with Hansoh disappointed investors in Viking Therapeutics, Terns Pharmaceuticals and Structure Therapeutics, which have been seen as acquisition targets. Shares in all three fell Wednesday.Dive Insight:Although Merck is an active developer of cardiovascular drugs, it hasnt advanced a novel metabolic medicine since its diabetes pill Januvia, which was approved in 2006. Januvia, and the metformin combination drug it calls Janumet, is still a blockbuster product, but sales have declined because of pricing pressure in the U.S. and generic competition overseas.With billions of dollars in revenue coming in from its cancer drug Keytruda, Merck has a big dealmaking war chest. Its choice to license an oral GLP-1 still in preclinical testing suggests Merck sees potential to enter the obesity market even though it trails Novo Nordisk, Eli Lilly, Pfizer and Roche.A licensing deal with Hansoh is relatively inexpensive, compared to a potential acquisition of U.S.-based biotechs like Viking and Structure that have multibillion-dollar market valuations. Merck has made two similarly small development deals with China-based biotechs in recent months: an oncology deal with LaNova Medicinesand an immunology pact with Curon Pharmaceutical.Analysts that cover Viking are still holding hope Merck could make more moves in obesity. We do not believe the licensing agreement with Hansoh will preclude Merck from expanding its presence in obesity through further external business development activities, William Blair analyst Andy Hsieh wrote in a Wednesday note to clients.Merck said it will record a $112 million pre-tax charge, or 4 cents a share, in its fourth quarter 2024 results because of the deal.Like Wegovy and other treatments in development, HS-10535 is a GLP-1 agonist, meaning it stimulates the hormones associated receptor. Hansoh has advanced an injectable drug that targets GLP-1 and another hormone called GIP into Phase 2 testing. '

Phase 2b ACCESS study designed to evaluate multiple doses up to 120 mg of GSBR-1290 over 36 weeks Comprehensive development program also includes Phase 2 ACCESS II study to evaluate even higher doses of GSBR-1290 over 36 weeks; first patient expected to be dosed by end of 2024 Topline data from both ACCESS and ACCESS II studies expected in the fourth quarter of 2025 Company to host conference call today at 4:30 p.m. Eastern Time Nov. 13, 2024 -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and pulmonary diseases, today announced the first patients have been dosed in the randomized, double-blind, placebo-controlled Phase 2b ACCESS clinical study evaluating GSBR-1290 in participants living with obesity, or overweight with a weight-related comorbidity. GSBR-1290 is an orally-available, nonpeptide small molecule glucagon-like-peptide-1 receptor (GLP-1R) agonist that has demonstrated competitive weight loss and generally favorable safety and tolerability results in previous studies with once-daily dosing. The Phase 2b ACCESS study is part of a comprehensive development program that also includes the Phase 2 ACCESS II study. ACCESS aims to enroll approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate multiple doses (up to 120 mg) of GSBR-1290 with an optimized “low and slow” titration regimen over 36 weeks. ACCESS II aims to enroll approximately 82 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate two additional higher doses of GSBR-1290 (180 and 240 mg) over 36 weeks, following the same titration scheme as the ACCESS study. Topline data from both the ACCESS and ACCESS II studies are expected in the fourth quarter of 2025. “We have designed the ACCESS and ACCESS II studies to generate a robust dataset to determine the target doses to move into Phase 3 clinical development with the goal of bringing GSBR-1290 to patients as rapidly as possible,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “In addition to its very competitive efficacy and tolerability profile, as an oral, nonpeptide small molecule GLP-1R agonist, we believe GSBR-1290 offers attractive manufacturing scalability advantages over peptide-based GLP-1R therapies, and we are excited to advance GSBR-1290 as our lead program. GSBR-1290 is just one of many compounds in our oral small molecule obesity portfolio, followed by our oral small molecule amylin development candidate which we expect to announce later this quarter.” “Our 36-week ACCESS study is designed to assess multiple therapeutic doses of GSBR-1290 with a start low and go slow 4-week titration approach to optimize tolerability and increase the likelihood of maximizing weight loss,” said Blai Coll, M.D., Ph.D., Chief Medical Officer of Structure Therapeutics. “Based on the data from our earlier studies, clean safety profile and proportional exposure of GSBR-1290, we are also initiating the ACCESS II study to evaluate higher doses of GSBR-1290. We look forward to data from both studies expected in the fourth quarter of 2025.” ACCESS is a randomized, double-blind, placebo-controlled, Phase 2b dose-range finding study of GSBR-1290 in approximately 220 adult participants living with obesity (body mass Index ≥ 30 kg/m2), or overweight (body mass index ≥ 27 kg/m2) with at least one weight-related comorbidity. Participants will start at 5mg of GSBR-1290 (or placebo) with a 4-week titration schedule, reaching target doses of 45 mg, 90 mg and 120 mg. The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of GSBR-1290. ACCESS II is a randomized, double-blind, placebo-controlled, Phase 2 dose-range finding study of GSBR-1290 in approximately 82 adult participants living with obesity, or overweight with at least one weight-related comorbidity. The study is designed to evaluate two higher doses of GSBR-1290. Participants will start at 5mg of GSBR-1290 (or placebo) and will follow a 4-week titration schedule up to target doses of 120 mg, 180 mg and 240 mg. GSBR-1290 is an orally-available, small molecule agonist of the glucagon-like-peptide-1 (GLP-1) receptor agonist, a validated drug target for the treatment of obesity and type 2 diabetes mellitus (T2DM). Through Structure Therapeutics’ structure-based drug discovery platform, GSBR-1290 was designed to be a biased GPCR agonist, which selectively activates the G-protein signaling pathway. Beyond GSBR-1290, Structure Therapeutics is developing next generation oral small molecules including amylin receptor agonists, and other combination GLP-1 receptor agonists candidates such as glucose-dependent insulinotropic polypeptide (GIP), glucagon and apelin oral small molecules. Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary 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 small molecule compounds designed to surpass the manufacturing scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. The content above comes from the network. if any infringement, please contact us to modify.