Terns Pharmaceuticals Announces Positive Clinical Trial Outcomes
Terns Pharmaceuticals Inc. reported positive outcomes from clinical trials of TERN-101 and TERN-501 for the treatment of non-alcoholic steatohepatitis (NASH).
The company stated that its Phase 2a trial will assess the safety and efficacy of TERN-101 after 12 weeks of treatment in NASH patients. TERN-101 was generally safe and well-tolerated at all doses tested, with no suspensions due to adverse reactions, including pruritus.
In the TERN-101 5 mg and 10 mg groups, no differences from placebo were observed in changes to low-density lipoprotein cholesterol or high-density lipoprotein cholesterol from baseline to week 12.
Terns reported that TERN-101 showed numerical decreases in alanine transaminase and MRI-proton density fat fraction in the 10 mg and 15 mg groups, with significant reductions in gamma-glutamyl transferase across all dose groups.
The company noted that TERN-501 was also well-tolerated, based on data from a single ascending dose cohort up to 60 mg. All single ascending doses of TERN-501 were safe, well-tolerated, and showed proportional plasma exposures with low variability.
Significant declines in LDL cholesterol, total cholesterol, and apolipoprotein B were observed by day 3 after a single dose of TERN-501, with dose-dependent decreases on day 4. TERN-501 also demonstrated significant effects on sex hormone-binding globulin.
Terns anticipates Phase 1b topline data for TERN-201 in NASH patients in the first quarter of 2022.
