Terns Pharmaceuticals Presents Late-Breaking Data from Phase 2a DUET Trial of THR-β Agonist TERN-501 in NASH at AASLD The Liver Meeting® 2023

TERN-501 treatment over 12 weeks significantly improved liver fat content and fibro-inflammation in NASH patients, with low rates of gastrointestinal and no cardiovascular adverse events

TERN-501 significantly increased SHBG, a marker of target engagement and predictor of histologic response in the THR-β class

Company to host in-person investor event following late-breaking data today at 4:00 p.m. ET in Boston

FOSTER CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- 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, obesity and non-alcoholic steatohepatitis (NASH), today announced the late-breaking oral presentation of top-line data from its Phase 2a DUET clinical trial of TERN-501, an investigational orally administered thyroid hormone receptor-β (THR-β) agonist for the treatment of NASH. TERN-501 was evaluated alone and in combination with the Company’s liver-distributed farnesoid X receptor (FXR) agonist TERN-101. These data will be presented at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), on Monday, November 13 at 2:00 p.m. ET in Boston, Massachusetts.

“NASH continues to be a serious, multi-faceted disease, and it is encouraging to see the additional evidence supporting the THR-β mechanism of action of TERN-501 to address these disease processes,” said Mazen Noureddin, M.D., MHSc, Professor of Medicine, Academic Institute, Houston Methodist, Director of Houston Research Institute, study presenter and principal investigator in the DUET trial. “The efficacy of TERN-501, showing a significant impact on steatosis and fibro-inflammation markers in a short period of time, coupled with its convenient oral once-daily dosing and highly positive safety profile, indicate that TERN-501 is a promising candidate for NASH treatment, either as a monotherapy or in combination with other therapies.”

In the Phase 2a DUET trial, patients with phenotypic or prior histologic NASH were randomized to one of seven treatments: once-daily, orally administered TERN-501 (1, 3 or 6 mg), TERN-101 (10 mg), TERN-501 (3 or 6 mg) combined with TERN-101 (10 mg), or placebo. The primary endpoint was the relative change from baseline in magnetic resonance imaging proton density fat fraction (MRI-PDFF), a measure of liver fat content, at Week 12 for TERN-501 monotherapy versus placebo. The study also assessed liver fibro-inflammation as measured by MRI corrected T1 (cT1), sex hormone binding globulin (SHBG) levels, a marker of THR-β agonism in the liver, lipid levels, and other fibrosis biomarkers as well as safety and tolerability following treatment.

Late-Breaking Phase 2a DUET Top-line Data to be Presented at AASLD The Liver Meeting

• TERN-501 (6 mg) monotherapy demonstrated significant reductions in liver fat content as early as Week 6
• The study met its primary endpoint, with TERN-501 monotherapy demonstrating a mean relative reduction of 27% (p=0.0036) and 45% (p