- Terns Pharmaceuticals Inc TERN reported top-line results from the Phase 2a LIFT trial of TERN-101, a liver-distributed farnesoid X receptor (FXR) agonist for the treatment of patients with non-alcoholic steatohepatitis (NASH).
- TERN-101 was generally well-tolerated in the trial with a similar incidence of adverse events across treatment groups.
- All treatment-related adverse events were mild/moderate with no apparent dose relationship.
- There were no treatment-related serious adverse events, and no patient discontinued TERN-101 due to any adverse event, including pruritus.
- The most frequent treatment-emergent adverse events included pruritus, headache, constipation, diarrhea, decreased appetite, and dizziness.
- 5 mg and 10 mg TERN-101 arms failed to achieve any change in LDL cholesterol (bad cholesterol), compared to placebo (Week 12 mean change: 4.8% for placebo, 6.7% for 5 mg TERN-101, 3.2% for 10 mg TERN-101, not significant).
- Statistically, significant LDL changes were observed only in the 15 mg arm (Week 12 mean change: 15.9%).
- Significant decreases in HDL cholesterol were observed in all TERN-101 dose groups at Week 4 and Week 8 but returned toward baseline in the 5 mg and 10 mg dose groups without differences from placebo at Week 12.
- Decreases in HDL were significantly different from placebo for the 15 mg group at all observed time points through Week 12.
- Terns plans to begin a TERN-101 and TERN-501 trial, a thyroid hormone receptor beta agonist (THR-β), for the treatment of NASH, in 1H 2022.
- Price Action: TERN shares are down 9.3% at $15.80 during the market session on the last check Monday.
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