Monday, Terns Pharmaceuticals Inc. 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.

周一，Terns Pharmaceuticals Inc.TERN公布了其第一阶段单次和多次递增剂量（SAD和MAD）试验的topline数据，以评估TERN-601每天一次给药的安全性，耐受性，药代动力学（PK）和药效学（PD）在肥胖或超重的健康成年人中（QD）。

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..

。。

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Additionally, 67% of participants lost 5% or more of their baseline body weight at the top dose.

此外，67%的参与者在最高剂量时体重减轻了基线体重的5%或更多。

“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..

“这些数据验证了TERN-601作为单一疗法或与我们内部发现的临床阶段THR-β激动剂TERN-501或我们TERN-800系列的GIPR调节剂等药物联合治疗肥胖症的潜力。随着运营准备工作的顺利进行，我们期待着在2025年将这一有希望的候选产品迅速推进到第二阶段临床开发，”Terns首席执行官艾米·巴勒斯（AmyBurroughs）说。。

“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.

TERN-601的首席医疗官Emil Kuriakose指出：“我们很高兴能证明它具有强大的GLP-1R激动作用，因为它独特的药物特性允许每天一次的剂量持续覆盖目标，并且评估剂量高达740毫克，同时可以耐受。”。

“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.

该公司表示，TERN-601的低溶解度和高肠道通透性可能导致长时间吸收，从而实现持续的靶标覆盖和平坦的PK曲线，而肠壁中的高药物水平可能导致肠道中强烈的GLP-1R激活，从而触发大脑中的饱腹感中心。

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.

此外，TERN-601在循环中具有低游离分数，结合平坦的PK曲线，当以高剂量给药时，可以允许TERN-601具有良好的耐受性。

Price Action: TERN stock is up 14.6% at $8.95 during the premarket session at last check Monday.

价格走势：TERN股价在周一最后一次检查的上市前交易中上涨14.6%，至8.95美元。

Photo: Illustration of Phrama lab worker created with MidJourney

照片：Phrama lab worker用MidJourney创作的插图

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