FDA 授予 CRV431 用于 NASH 治疗的快速通道指定

StephenW

FDA 授予 CRV431 用于 NASH 治疗的快速通道指定
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根据 Hepion Pharmaceuticals 的一份新闻稿，FDA 授予 CRV431 快速通道指定，这是一种强效亲环蛋白抑制剂，用于治疗非酒精性脂肪性肝炎患者。

根据新闻稿，该指定允许申办者在严重和可能危及生命的医疗状况以及未满足的需求的情况下获得药物批准审查。

Hepion 首席医疗官 Todd Hobbs 医学博士说：“我们敏锐地意识到，全球仍然迫切需要为这种可能危及生命的疾病开发 NASH 特异性治疗药物，目前还没有 FDA 批准的药物。”在新闻稿中。 “此外，美国肝脏基金会估计，美国成年人口中至少有 5% 患有 NASH。因此，我们很高兴获得 FDA 的快速通道指定，并期待在我们推进 CRV431的开发过程中与该机构密切合作。”

根据 Hobbs 的说法，CRV431 在 Hepion 的 1 期计划期间对健康患者进行了调查，最近在其 2a 期研究中对推定为 F2 和 F3 NASH 期的患者进行了调查。口服软胶囊每天给药一次，耐受性良好，显示出对 NASH 的疗效信号。

“这一快速通道指定提供了与 FDA 的早期和频繁沟通，这将在整个药物开发和审查过程中继续进行，这可能会导致更快的药物批准和患者获得 CRV431，”罗伯特福斯特，药学博士，博士，首席执行官Hepion 在发布会上说。

Hepion 旨在在活检证实的 NASH 患者中启动一项更大的 2b 期研究。

StephenW

FDA grants fast track designation to CRV431 for NASH treatment
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The FDA granted fast track designation to CRV431, a potent cyclophilin inhibitor, for the treatment of patients with nonalcoholic steatohepatitis, according to a release from Hepion Pharmaceuticals.

The designation allows sponsors to access drug approval reviews for serious and potentially life-threatening medical conditions and where there is an unmet need, according to the release.

“We are keenly aware that there remains an urgent global need to develop NASH-specific therapeutic drugs for this potentially life-threatening condition for which there are currently no FDA-approved drugs,” Todd Hobbs, MD, chief medical officer for Hepion, said in the press release. “Furthermore, the American Liver Foundation estimates that at least 5% of the U.S. adult population has NASH. As such, we are very pleased to receive the FDA’s fast track designation and are looking forward to working closely with the agency as we advance development of CRV431.”

According to Hobbs, CRV431 underwent investigation among healthy patients during Hepion’s phase 1 program and, more recently, among patients with presumed stage F2 and F3 NASH in its phase 2a study. The oral soft gel capsule was administered once daily and was well tolerated, showing signals of efficacy in NASH.

“This fast track designation provides for early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to a more expedited drug approval and patient access to CRV431,” Robert Foster, PharmD, PhD, CEO for Hepion, said in the release.

Hepion aims to initiate a larger phase 2b study among patients with biopsy-confirmed NASH.