Gannex宣布了一项在美国临床研究中首次使用THR-β激动剂ASC41

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Gannex Announces the First Cohort Dosed in a U.S. Clinical Study with THR-β Agonist ASC41

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Ascletis Pharma Inc.

Apr 14, 2021, 08:00 ET
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SHANGHAI, April 14, 2021 /PRNewswire/ -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces the dosing of the first cohort in the U.S. Phase I clinical study of drug interaction and non-alcoholic fatty liver disease (NAFLD) patient pharmacokinetics for ASC41 oral tablets, a liver-targeted prodrug. The active metabolite of ASC41 is a selective thyroid hormone receptor beta (THR-β) agonist.

On 25 February 2021, Gannex announced the Investigational New Drug Application (IND) approval by the U.S. Food and Drug Administration (FDA) for ASC41 oral tablets.

This clinical study consists of two cohorts: the first cohort is a drug-drug interaction study to evaluate the effect of itraconazole and phenytoin on the pharmacokinetics of ASC41 oral tablets in healthy volunteers, and the second cohort is a study to evaluate the pharmacokinetics, safety and tolerability of ASC41 oral tablets in patients with NAFLD.

Melissa Palmer, MD, Chief Medical Officer of Gannex, said, "We are excited about the dosing of the first cohort in the U.S. only one and half a months after IND approval by the FDA. This demonstrates the execution excellence of our clinical development team and the dedication of Gannex to the development of a drug for patients with NASH."

Dr. Handan He, Chief Scientific Officer of Ascletis, said, "This study will offer important drug interaction information and pharmacokinetic data in patients with NAFLD which will accelerate our global clinical development for ASC41 oral tablets."  

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer lipid metabolism and oral checkpoint inhibitors, viral hepatitis and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.

Ascletis has three marketed products and seventeen R&D pipeline drug candidates or combination therapies (eleven of them developed in-house). 1. NASH: Gannex, a wholly-owned company of Ascletis, is fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three pre-clinical stage combination therapies. 2. Cancer lipid metabolism and oral checkpoint inhibitors: focus on a pipeline of oral inhibitors targeting FASN which plays a key role in cancer lipid metabolism and a pipeline of oral PD-L1 small molecule inhibitors as the next generation checkpoint inhibitors. 3. Viral hepatitis: (i) Hepatitis B: focus on breakthrough therapies for HBV clinical cure with subcutaneously injected PD-L1 antibody - ASC22 and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched all oral regimen of ASCLEVIR® and GANOVO® combination (RDV/DNV regimen); and ASC18 fixed dose combination (FDC) is an upgraded version of RDV/DNV regimen with bridging study finished. 4. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit www.ascletis.com.

SOURCE Ascletis Pharma Inc.

StephenW

Gannex宣布了一项在美国临床研究中首次使用THR-β激动剂ASC41进行的队列研究

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Ascletis Pharma Inc.

美国东部时间2021年4月14日，08：00
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2021年4月14日，上海，上海-Gannex是Ascletis Pharma Inc.（HKEX：1672）的全资公司，致力于非酒精性脂肪性肝炎（NASH）领域的新药研发和商业化，今天宣布在美国进行针对药物相互作用和非酒精性脂肪肝疾病（NAFLD）患者药代动力学的I期临床研究的第一批研究，该药物是针对肝脏的前药ASC41口服片剂。 ASC41的活性代谢产物是选择性甲状腺激素受体β（THR-β）激动剂。

2021年2月25日，Gannex宣布了美国食品药品监督管理局（FDA）批准的ASC41口服片剂新药研究性批准（IND）。

该临床研究包括两个队列：第一个队列是药物-药物相互作用研究，用于评估伊曲康唑和苯妥英钠对健康志愿者中ASC41口服片剂药代动力学的影响，第二个队列是评估药代动力学，安全性的研究NAFLD患者的ASC41口服片剂的耐药性和耐受性。

Gannex首席医学官医学博士Melissa Palmer表示：“我们对FDA批准IND仅仅一个半月后在美国的第一批患者的给药感到兴奋。这证明了我们临床开发团队的卓越执行能力以及Gannex致力于为NASH患者开发一种药物。”

Ascletis首席科学官Handan He博士说：“这项研究将为NAFLD患者提供重要的药物相互作用信息和药代动力学数据，这将加快我们ASC41口服片剂的全球临床开发。”

关于Ascletis

Ascletis是一家创新的研发驱动型生物技术，已在香港联合交易所（1672.HK）上市。 Ascletis致力于在NASH，癌症脂质代谢和口服检查点抑制剂，病毒性肝炎和HIV / AIDS等领域开发创新药物并将其商业化，以满足中国乃至全球的医疗需求。在拥有深厚专业知识和成功经验的管理团队的带领下，Ascletis已经发展成为一个完全集成的平台，涵盖了从发现，开发到制造和商业化的整个价值链。

Ascletis有3种上市产品和17种研发中的候选药物或联合疗法（其中11种是在内部开发的）。 1. NASH：Gannex是Ascletis的全资公司，完全致力于NASH领域中新药的研发和商业化。 Gannex针对三种不同目标（FASN，THR-beta和FXR）具有三种临床阶段候选药物，以及三种临床前阶段联合疗法。 2.癌症脂质代谢和口服检查点抑制剂：专注于针对FASN的一系列口服抑制剂，FASN在癌症脂质代谢中起关键作用，以及作为下一代检查点抑制剂的口服PD-L1小分子抑制剂。 3.病毒性肝炎：（i）乙型肝炎：专注于突破性疗法，以皮下注射的PD-L1抗体-ASC22和Pegasys®作为基础药物，可用于HBV临床治愈。 （ii）丙型肝炎：成功启动了ASCLEVIR®和GANOVO®联合治疗的所有口服方案（RDV / DNV方案）； ASC18固定剂量组合（FDC）是RDV / DNV方案的升级版，已完成桥接研究。 4. HIV / AIDS：ASC09F是FDC治疗HIV靶向蛋白酶。 ASC09F的临床试验应用已获得批准。有关更多信息，请访问www.ascletis.com。

消息来源Ascletis Pharma Inc.