Terns Pharmaceuticals, Inc. has released the topline 12-week data from its phase 2 trial evaluating oral GLP-1 receptor agonist Tern-601 in obesity. The results show a maximum placebo-adjusted weight loss of 4.6%, with 12% treatment discontinuation due to adverse events. The company has decided not to advance Tern-601 or invest in other metabolic assets, reiterating its focus on Tern-701, a potential best-in-class allosteric BCR-ABL inhibitor for chronic myeloid leukemia, with clinical data expected to be released this quarter.
In the trial, baseline characteristics were generally well-balanced across the treatment arms, with participants predominantly female (78-79%) and a mean age range of 47-53 years. The mean weight and body mass index (BMI) ranges were 99-102 kg and 36-37 kg/m2, respectively.
Statistically significant weight loss was observed at doses greater than 500 mg, with the placebo-adjusted weight loss percentages as follows: 250 mg (-1.8%), 500 mg slow titration (-3.6%), 500 mg (-4.6%), and 750 mg (-3.0%).
Regarding safety and tolerability, 11.9% of participants who received Tern-601 discontinued treatment due to adverse events, with the majority of these events being gastrointestinal (GI) related. The most common GI adverse events were nausea (56%), vomiting (26.9%), and constipation (11.9%). It is noted that there were no severe GI adverse events in any group, and the rates of GI adverse events were overall stable over the treatment period.
Despite the generally stable liver function tests during the treatment period, three participants experienced grade 3 liver enzyme elevations during the post-treatment follow-up. Two of these cases were deemed drug-related, and the third had an alternate etiology. The company plans to publish detailed results from the phase 2 trial in the future.
The Falcon phase 2 trial, a U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial, evaluated the efficacy and safety of Tern-601 in adults with obesity or who are overweight, without diabetes. The primary endpoint was the percent change from baseline in body weight compared to placebo over 12 weeks, with secondary endpoints including safety, tolerability, and the proportion of participants achieving 5% weight loss or greater.
Terns Pharmaceuticals, Inc. is focusing on developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, with a decision not to further invest in metabolic disease and a commitment to advancing the potentially best-in-class Tern-701 program in chronic myeloid leukemia. Today the company's shares have moved -5.8% to a price of $8.12. For more information, read the company's full 8-K submission here.
