Terns Pharmaceuticals announces late-breaking data from Phase 2a DUET trial

Terns Pharmaceuticals 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-beta agonist for the treatment of NASH. TERN-501 was evaluated alone and in combination with the Company’s liver-distributed farnesoid X receptor vagonist TERN-101. These data will be presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, on Monday, November 13 at 2:00 p.m. ET in Boston, Massachusetts. TERN-501 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% and 45% at 3 mg and 6 mg doses, respectively, versus a 4% reduction in the placebo group at Week 12; A significantly higher percentage of patients achieved a greater than or equal to30% MRI-PDFF reduction in TERN-501 arms and a greater than or equal to50% reduction with TERN-501 monotherapy at Week 12; TERN-501 monotherapy resulted in a significant and rapid decrease in cT1 with a significantly higher percentage of patients achieving a greater than or equal to80 ms reduction; TERN-501 combined with TERN-101 resulted in efficacy improvement or maintenance compared to TERN-501 monotherapy TERN-501 monotherapy arms demonstrated significant increases in SHBG and improved lipid levels, including significant reductions in apolipoprotein B and a decrease in low-density lipoprotein levels, when combined with TERN-101; TERN-501 was generally well tolerated, with treatment-related adverse events similar to the placebo group; Overall, there were low rates of gastrointestinal AEs reported similarly across all treatment arms; No treatment-related cardiovascular AEs or serious AEs were reported.