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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. |
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