Hepion Pharmaceuticals Receives FDA Authorization to Proceed with IND Opening Study of CRV431 for NASH
“We are delighted that the
“This is an important milestone that allows us to continue with CRV431’s clinical development for NASH in addition to HBV. We look forward to commencing our IND opening study this year, which will assess CRV431 in patients with varying degrees of hepatic impairment.”
Hepion’s planned IND opening study, entitled “An Open-Label Single-Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431,” will enroll 24 patients consisting of eight with mild, eight with moderate, and eight with severe hepatic impairment, based on established Child-Pugh scores. Up to an additional 24 healthy subjects will serve as the control group. The objective of the IND opening study and proposed clinical development program is to characterize the safety, tolerability and pharmacokinetics of CRV431 monotherapy in patients with liver disease to establish dose ranges for patients with differing degrees of NASH.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain
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Hepion Pharmaceuticals Investor Relations
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Source: Hepion Pharmaceuticals, Inc.