Terns Pharmaceuticals Inc. (TERN) has released positive topline data from its Phase 1 clinical trial for TERN-601, a potential new treatment for obesity. The trial, which assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or overweight, showed promising results.
The single and multiple-ascending dose (SAD and MAD) trial, where participants received once-daily doses of TERN-601, demonstrated that the drug was well-tolerated across all doses. Moreover, the study revealed statistically significant placebo-adjusted mean weight loss in a dose-dependent manner. The highest dose of 740 mg QD resulted in a maximum placebo-adjusted mean weight loss of 4.9% over 28 days. Notably, 67% of participants at the highest dose achieved a weight loss of 5% or more from their baseline.
These results highlight the potential of TERN-601 as a monotherapy or in combination with other weight-loss agents. Terns plans to advance TERN-601 into Phase 2 clinical development in 2025.
“These data validate the potential of TERN-601 for the treatment of obesity as monotherapy or in combination with agents such as TERN-501, our internally discovered, clinical stage THR-β agonist, or a GIPR modulator from our TERN-800 series,” said Amy Burroughs, chief executive officer of Terns.
The company attributes TERN-601’s efficacy to its unique properties, including its low solubility and high gut permeability, which allow for sustained target coverage and a flat PK curve. This, coupled with high drug levels in the gut wall, triggers robust GLP-1R activation in the gut, leading to satiety signals in the brain. The low free fraction in circulation and flat PK curve contribute to the drug’s good tolerability at high doses.
The positive Phase 1 results have led to a surge in TERN stock, which is up 14.6% during the premarket session. The company’s focus on developing novel therapies for obesity, a growing global health concern, has attracted significant interest in the market.
This news comes at a time when the weight-loss market is experiencing significant growth, driven by an increasing prevalence of obesity and the emergence of new and effective medications.
