Hepion Pharmaceuticals Announces Dosing of First HBV Patient in 28-Day Study of CRV431
August 14 2019 - 8:30AM
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.
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 FDA clearances or
approvals and noncompliance with FDA regulations. As with any drug
candidates under development, there are significant risks in the
development, regulatory approval, and commercialization of new
products. There are no guarantees that future clinical trials
discussed in this press release will be completed or successful, or
that any product will receive regulatory approval for any
indication or prove to be commercially successful. Hepion
Pharmaceuticals does not undertake an obligation to update or
revise any forward-looking statement. Investors should read the
risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the
year ended December 31, 2018 and other periodic reports filed with
the Securities and Exchange Commission.
For further information, please contact:
Stephen KilmerHepion Pharmaceuticals Investor RelationsDirect:
(646) 274-3580skilmer@hepionpharma.com
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