Terns Pharmaceuticals Inc (Nasdaq:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, on Tuesday reported topline 12-week results from its Phase 2 trial of TERN-601, a novel, once-daily, oral GLP-1 receptor agonist (GLP-1RA) as a potential treatment for obesity.

"The threshold for a truly differentiated oral GLP-1RA therapy -- one that delivers safety, tolerability and efficacy -- is high. The Phase 2 topline 12-week results for TERN-601 did not meet this threshold and likely preclude further development," said Amy Burroughs, Terns CEO. "As we've previously communicated, we do not plan to further invest in metabolic disease. Our team remains energised and focused on advancing our potentially best-in-class TERN-701 programme in chronic myeloid leukaemia (CML) with our full capabilities. We look forward to announcing new data from our Phase 1 CARDINAL trial of TERN-701 for CML this quarter."

Emil Kuriakose, M.D., Terns chief medical officer, added: "The results of our previous Phase 1 inpatient 28-day trial did not translate to those we observed in this 12-week trial, which was conducted in an outpatient multi-centre setting. The post-treatment reversible grade 3 liver enzyme elevations were unexpected based on the lack of similar signals in preclinical and Phase 1 studies."

The FALCON Phase 2 trial is a US-based, multicentre, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of TERN-601, a novel oral GLP-1R agonist, with once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes. Detailed results from the trial will be published in the future.