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 dosing
- Dose related increase in weight loss with 67% of patients losing 5% or more body weight at top dose
- Unique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hours
- Higher 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 titration
- No meaningful changes in liver enzymes, vital signs or ECGs
- Tolerability and ease of use
- Simplest dose titration amongst GLP1-RA therapies
- Dosing with or without food
- Can be administered with PPIs, H2RA and/or antacids
The presentations and viewing detail are listed below:
| Presentation Title: | Effect of Oral Small Molecule GLP-1 Receptor Agonist TERN-601 in Healthy Participants with Obesity or Overweight – A First-in-Human Study |
| Abstract Number: | 307-OR |
| Presentation Date and Time: | Monday, June 23, 2025; 2:30-2:45 PM CT |
| Session Name: | Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials with lncretin-Based Therapies-Take 2 |
| Presenter: | Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA |
| Presentation Title: | No Effect of Food or Proton Pump Inhibitor on the Pharmacokinetics of TERN-601, an Oral Small Molecule GLP-1 Receptor Agonist |
| Abstract Number: | 767-P |
| Presentation Date and Time: | Sunday Jun 22, 2025; 12:30 PM - 1 :30 PM CT |
| Session Name: | Clinical Therapeutics-lncretin-Based Therapies |
| Presenter: | Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA |
About the TERN-601 Phase 1 Trial
The Phase 1 trial was a randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or overweight. The trial consisted of two parts.
Part 1 (SAD) was a single ascending dose study that evaluated five TERN-601 dose levels in healthy participants with a Body Mass Index (BMI) of ≥ 25 kg/m2 and < 40 kg/m2. The starting TERN-601 dose was 30 mg, with subsequent dose levels based on review of emerging safety and PK data from prior cohorts.
In Part 2 (MAD) of the trial, obese and overweight healthy adults were enrolled in cohorts that included titration of TERN-601 administered for 28 days at doses selected based on data from Part 1 (SAD). Part 2 included healthy participants with a BMI of ≥ 27 kg/m2 to < 40 kg/m2.
The primary endpoint of the trial was to evaluate safety and tolerability of TERN-601 administered once-daily for 28 days. Secondary endpoints included PK, efficacy as measured by body weight loss following 28 days of treatment with TERN-601, and other exploratory markers.
About FALCON Phase 2 Trial
FALCON is an ongoing U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601, with once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to