Hepion Pharmaceuticals宣布在为期28天的CRV431研究中给予首例HBV患

StephenW

Hepion Pharmaceuticals Announces Dosing of First HBV Patient in 28-Day Study of CRV431
Study Represents the Third and Final Stage of CRV431’s Streamlined Early Clinical Program

EDISON, N.J., Aug. 14, 2019 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced that it has dosed the first patient in a 28-day multiple ascending dose clinical trial of CRV431.

Designed to assess safety, tolerability and pharmacokinetics of CRV431, this study is the third and final stage of CRV431's streamlined early clinical program, which was agreed upon with the U.S. Food and Drug Administration (“FDA”).

Patients in four cohorts will be administered CRV431 in doses ranging from 75 mg to 375 mg in combination with 300 mg tenofovir disoproxil fumarate (TDF) antiviral therapy, over a 28-day period. Each cohort is comprised of four patients, equally divided between hepatitis B e-antigen (“HBeAg”) positive and negative.

“Having established safety and tolerability of CRV431 alone, as well as when co-dosed with TDF, this trial will monitor safety, tolerability and pharmacokinetics of CRV431 when administered repeatedly for 28 days in virally-suppressed HBV patients,” stated Dr. Foster, Hepion’s CEO. “Although the study’s focus will be on markers of safety, we will also look for any anti-viral and anti-fibrotic activity.”

The study will include a fifth dosing cohort of HBV patients with Metavir scores, a measure of inflammation and fibrosis, of F2/F3. These patients will be administered 225 mg CRV431 to analyze exploratory markers of HBV infection and liver fibrosis.

“CRV431 is a promising candidate for HBV patients who still need therapies in the absence of a cure,” said Dr. Stephen Harrison of Pinnacle Clinical Research and a Visiting Professor of Hepatology at Radcliffe Department of Medicine, University of Oxford. “As a new class of drug for liver disease with a novel mechanism of action, CRV431 has the potential to decrease viral markers and fibrosis.”

In the first stage of CRV431’s streamlined clinical program, CRV431 met the primary endpoints of safety and tolerability in a single ascending dose study of healthy volunteers. In the second stage, Hepion confirmed the safety of co-dosing CRV431 and TDF in a single-dose, drug-drug interaction study in healthy subjects.

About CRV431

CRV431 is a clinical stage cyclophilin inhibitor. Its primary biochemical action is inhibition of cyclophilin isomerase activity, which is known to play a key role in protein folding. In non-clinical, experimental models of NASH, CRV431 reduced fibrosis scores and hepatocellular carcinoma (HCC) tumor burden. In addition, CRV431 has also shown activity against certain viruses including HBV, HCV, and HIV-1. CRV431 has demonstrated an ability to reduce multiple markers of HBV infection including reductions in DNA, HBsAg, HBeAg, and HBV uptake by liver cells. These multiple modes of action may play an important role in the overall treatment of liver disease, from triggering events through to end-stage liver disease. CRV431 has completed phase 1 human clinical trials.
About Hepion Pharmaceuticals

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The Company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.

StephenW

Hepion Pharmaceuticals宣布在为期28天的CRV431研究中给予首例HBV患者剂量
研究代表了CRV431简化的早期临床计划的第三阶段和最后阶段

新泽西州EDISON，2019年8月14日（全球新闻） -  Hepion Pharmaceuticals，Inc。（纳斯达克股票代码：HEPA），一家生物制药公司，专注于开发治疗由非酒精性脂肪性肝炎引起的肝病的治疗药物（ NASH“）和慢性病毒感染，今天宣布它已经在CRV431的28天多次递增剂量临床试验中给第一名患者服用。

该研究旨在评估CRV431的安全性，耐受性和药代动力学，是CRV431简化的早期临床计划的第三和最后阶段，该计划已与美国食品和药物管理局（“FDA”）达成一致。

在28天期间，四个队列中的患者将施用剂量范围为75mg至375mg的CRV431与300mg替诺福韦地索普西富马酸盐（TDF）抗病毒治疗组合。每个队列由4名患者组成，在乙型肝炎e抗原（“HBeAg”）阳性和阴性之间平均分配。

“在单独使用CRV431时，以及与TDF共同给药时，该试验将监测CRV431在病毒抑制的HBV患者中重复给药28天的安全性，耐受性和药代动力学，”Foster博士说， Hepion的首席执行官。 “尽管该研究的重点是安全标记，但我们也会寻找任何抗病毒和抗纤维化活性。”

该研究将包括HBV患者的第五剂量组，其具有F2 / F3的炎症和纤维化的Metavir评分。这些患者将给予225mg CRV431以分析HBV感染和肝纤维化的探索性标志物。

“在没有治愈的情况下仍然需要治疗的HBV患者，CRV431是一个很有前景的候选人，”Pinnacle临床研究的Stephen Harrison博士和牛津大学Radcliffe医学系的肝病学客座教授说。 “作为一种具有新型作用机制的新型肝病药物，CRV431具有降低病毒标志物和纤维化的潜力。”

在CRV431简化临床计划的第一阶段，CRV431在健康志愿者的单次递增剂量研究中符合安全性和耐受性的主要终点。在第二阶段，Hepion在健康受试者的单剂量药物相互作用研究中证实了共同给药CRV431和TDF的安全性。

关于CRV431

CRV431是临床阶段的亲环蛋白抑制剂。其主要的生物化学作用是抑制亲环蛋白异构酶活性，已知其在蛋白质折叠中起关键作用。在NASH的非临床实验模型中，CRV431降低了纤维化评分和肝细胞癌（HCC）肿瘤负荷。此外，CRV431还显示出对某些病毒的活性，包括HBV，HCV和HIV-1。 CRV431已证明能够减少HBV感染的多种标志物，包括肝细胞对DNA，HBsAg，HBeAg和HBV摄取的减少。这些多种作用模式可能在肝脏疾病的整体治疗中发挥重要作用，从触发事件到终末期肝病。 CRV431已完成第1阶段人体临床试验。
关于Hepion Pharmaceuticals

Hepion Pharmaceuticals是一家临床阶段的生物制药公司，专注于开发针对非酒精性脂肪性肝炎（NASH）和慢性肝炎病毒感染（HBV，HCV，HDV）引起的肝病的靶向治疗。该公司的主要候选药物CRV431可降低NASH实验模型中的肝纤维化和肝细胞癌肿瘤负担。临床前研究还通过几种机制证明了对HBV，HCV和HDV的抗病毒活性。这些不同的治疗活动源于CRV431对环亲蛋白酶的有效抑制，亲环蛋白酶参与许多疾病过程。目前在临床阶段的发展中，CRV431显示出在肝脏疾病的整体治疗中发挥重要作用的潜力 - 从触发事件到终末期疾病。

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