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Monday, Terns Pharmaceuticals Inc. (NASDAQ:TERN) revealed topline data from its Phase 1 single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TERN-601 dosed once-daily (QD) in healthy adults with obesity or overweight.
The clinical trial results showed TERN-601 was well tolerated and demonstrated dose-dependent, statistically significant placebo-adjusted mean weight loss across all three doses evaluated in the 28-day MAD study, with maximum placebo-adjusted mean weight loss of 4.9% at the highest dose of 740 mg QD.
Additionally, 67% of participants lost 5% or more of their baseline body weight at the top dose.
“These data validate the potential of TERN-601 for the treatment of obesity as monotherapy or in combination with agents such as TERN-501, our internally discovered, clinical stage THR-β agonist, or a GIPR modulator from our TERN-800 series. With operational preparations well underway, we look forward to swiftly advancing this promising product candidate into Phase 2 clinical development in 2025,” said Amy Burroughs, chief executive officer of Terns.
“We are delighted to demonstrate potent GLP-1R agonism with TERN-601 as its distinct drug properties allowed for sustained target coverage with once-daily dosing and the evaluation of doses up to 740 mg, while being tolerable,” noted Emil Kuriakose, chief medical officer of Terns.
“Importantly, we believe we have successfully identified an optimal range of clinically active, well-tolerated doses to take forward in Phase 2 clinical trials, with no new dose range exploration anticipated.”
The company says TERN-601’s low solubility and high gut permeability may result in prolonged absorption, allowing for sustained target coverage and a flat PK curve, while high drug levels in the gut wall may lead to robust GLP-1R activation in the gut, triggering satiety centers in the brain.
Additionally, TERN-601 has a low free fraction in circulation which, combined with the flat PK curve, may be allowing TERN-601 to be well tolerated when administered at high doses.
Price Action: TERN stock is up 14.6% at $8.95 during the premarket session at last check Monday.
Photo: Illustration of Phrama lab worker created with MidJourney
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