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Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions
Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024 Phase 2 FALCON clinical
About this update from Terns Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024 Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025 FOSTER CITY, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that data from the completed Phase 1 study of TERN-601, a novel once-daily oral GLP-1R agonist, will be highlighted at the American Diabetes Association (ADA) 85th Scientific Sessions, taking place June 20-23, 2025, in Chicago, IL. “We are thrilled to be selected for an oral presentation at ADA to highlight additional data from the 28-day Phase 1 study of TERN-601 demonstrating its differentiated profile among oral GLP1-R agonists,” said Amy Burroughs, chief executive officer of Terns. “In addition, we are pleased to share the recent completion of enrollment for our Phase 2 FALCON trial where the key objectives of the trial are to demonstrate TERN-601’s competitive weight loss at 12-weeks, a class leading safety and tolerability profile, and the simplest dose titration amongst GLP-1R agonist therapies.” Topline data from the Phase 1 clinical study being presented at ADA were reported in September 2024 and provided the recommended doses taken forward in the ongoing Phase 2 FALCON study, which recently completed enrollment, with topline data expected in the fourth quarter of 2025. Key highlights from the ADA presentation include: Efficacy Statistically significant and dose-dependent weight loss up to 5.5% over 28 days with QD dosingDose related increase in weight loss with 67% of patients losing 5% or more body weight at top doseUnique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hoursHigher gut vs. plasma exposures and low free fraction drives meaningful weight loss without sacrificing tolerability Safety Well-tolerated despite rapid dose titration every three days No treatment related interruptions, reductions, discontinuations at any dose>95% of GI AEs were mild despite rapid titrationNo meaningful changes in liver enzym...