FOSTER CITY - 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, announced 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, chief executive officer of Terns. 'As we've previously communicated, we do not plan to further invest in metabolic disease. Our team remains energized and focused on advancing our potentially best-in-class TERN-701 program in chronic myeloid leukemia (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.'
'We would like to thank all the trial participants, investigators, caregivers, clinical sites, and Terns team members for their support and involvement in this well-run Phase 2 trial,' said Emil Kuriakose, M.D., chief medical officer of Terns. '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-center 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,' added Dr. Kuriakose. 'We plan to publish detailed results from the Phase 2 trial in the future.'
Topline Results Summary
Baseline Characteristics
Baseline characteristics were generally well-balanced across the treatment arms
Participants were predominantly female (78-79%), mean age range was 47-53 years of age, with mean weight and body mass index (BMI) ranges of 99-102 kg and 36-37 kg/m2, respectively
Safety and Tolerability
Of the 134 participants who received TERN-601, 11.9% and 8.2% discontinued treatment or had dose modification due to adverse events (AEs), respectively, the majority of which were gastrointestinal (GI) related
GI AEs were all mild or moderate, most commonly nausea (56%), vomiting (26.9%), constipation (11.9%), diarrhea (9.7%) and appeared to be dose related
There were no severe GI AEs in any group; rates of GI AEs were overall stable over the treatment period
Across all participants, mean AST, ALT, alkaline phosphatase, and total bilirubin remained overall stable during the treatment period. No participants had dose interruption, reduction, or discontinuation due to abnormal liver function tests (LFTs) during the treatment period
Of three participants who had grade 3 LFT elevations during the post-treatment follow up, two participants in the 500 mg treatment arm had profiles consistent with drug induced liver injury (DILI) (one supported by findings on liver biopsy). The LFT elevations in the third participant (750 mg) had an alternate etiology of gall stones and was deemed unlikely to be drug-related by the investigator, although DILI could not be definitively ruled out. The investigator-reported assessments for all three participants agreed with the independent adjudication of the three cases by a DILI Network expert clinician
Phase 2 FALCON Trial
The FALCON Phase 2 trial is a U.S.-based, multicenter, randomized, 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
BMI ranges from =30 to
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