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Terns Pharmaceuticals Inc (NASDAQ: 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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