ACCG-2671 / Structure Therap, Schrodinger - LARVOL DELTA

Oral Small Molecule Amylin Receptor Agonists for the Treatment of Obesity or Overweight with Comorbidities (GlobeNewswire) - "ACCG-2671 – Investigational new drug enabling activities for ACCG-2671 are ongoing, with the initiation of a first-in-human Phase 1 clinical study expected by year-end 2025....A second dual amylin and calcitonin receptor agonist development candidate, ACCG-3535, has been selected. ACCG-3535 is a unique chemical structure from ACCG-2671. Preclinical ACCG-3535 data were recently presented at Obesity Week 2025 demonstrating high binding affinity to human amylin and calcitonin receptors and balanced potency in human amylin and calcitonin receptor functional assays. In addition, ACCG-3535 demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats."

New P1 trial • Preclinical • Obesity

A Novel, Potent Small Molecule Dual Amylin and Calcitonin Receptor Agonist for Obesity Treatment (OBESITY WEEK 2025) - " A novel small molecule, differentiated from ACCG-2671, showed sub-nanomolar binding affinity to human AMY3R (hAMY3R) and human CTR (hCTR)... Our novel small molecule DACRA showed high potency and efficacy in vitro and in vivo, with PK properties predicting once-daily oral dosing in humans. This molecule demonstrated a promising preclinical profile, reflecting our multi-generational approach to small molecule discovery and supporting the further development of the new molecule as a novel treatment for obesity."

Genetic Disorders • Obesity

Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights (GlobeNewswire) - "ACCG-2671 - Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 was presented in a late-breaking poster session at the American Diabetes Association 85th Scientific Sessions in June 2025....In diet-induced obese rats, oral administration of ACCG-2671 resulted in significant, dose-dependent body weight reductions. Combination therapy with semaglutide (both as add-on and concurrent treatment) resulted in superior weight loss compared to monotherapy of either compound."

New P1 trial • Preclinical • Obesity

Novel Oral Small Molecule ACCG-2671—A Dual Amylin and Calcitonin Receptor Agonist Development Candidate for Obesity Therapy (ADA 2025) - "Cagrilintide, a long-acting dual amylin and calcitonin receptor agonist (DACRA) peptide, has demonstrated promising efficacy and safety profile in clinical trials, but an oral small molecule DACRA with good bioavailability and stability could provide a more convenient and accessible alternative for obesity treatment. ACCG-2671 is a novel oral small molecule DACRA that significantly reduces body weight in obese rats. Its pharmacological profile and preclinical efficacy support its advancement as a development candidate, alone and in combination for obesity treatment, potentially offering a novel, convenient, and accessible therapeutic option."

Late-breaking abstract • Metabolic Disorders • Obesity

Structure Therapeutics Announces...Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671 (GlobeNewswire) - "Structure Therapeutics...announced two upcoming late-breaking poster presentations at the American Diabetes Association 85th Scientific Sessions....“We believe ACCG-2671...is expected to enter clinical development by the end of 2025'....'The preclinical data being presented at ADA include the robust weight-loss effects of ACCG-2671 alone and in combination with a GLP-1 receptor agonist underscoring ACCG-2671’s potential as a future small molecule backbone treatment for obesity'."

Late-breaking abstract • Preclinical • Obesity

Structure Therapeutics Reports First Quarter 2025 Financial Results and Recent Highlights (GlobeNewswire) - "Recent and Upcoming Milestones: Aleniglipron (GSBR-1290); The Phase 2b ACCESS and ACCESS II studies are fully enrolled and on track for topline 36-week data by year-end 2025....ACCG-2671: Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 will be presented in a late-breaking poster session at the American Diabetes Association (ADA) 85th Scientific Sessions on June 22, 2025....Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss....Long term chronic GLP-toxicology studies are currently underway and expected to be completed in 2025....Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $42.9 million, as compared to $20.7 million for the same period in 2024."

Commercial • New P1 trial • P2b data • Preclinical • Trial completion date • Obesity

Structure Therapeutics Announces Selection of Lead Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity (GlobeNewswire) - "Structure Therapeutics...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....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....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."

New P1 trial • Pipeline update • Preclinical • Obesity