Hepion Pharmaceuticals Highlights Upcoming Phase 2 Clinical Trials of Recofilstat at 5th Global NASH Congress
May 27 2022 - 7:00AM
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma
(“HCC”), announces that its Chief Medical Officer, Todd Hobbs, MD,
gave a clinical presentation entitled “Recofilstat (CRV431): A
liver-targeting drug candidate for NASH and HCC” today at the 5th
Global NASH Congress.
During the presentation, Dr. Hobbs reviewed
additional data from the positive Phase 2a ‘AMBITION’ NASH clinical
trial, and provided further details on three upcoming clinical
studies of its lead drug candidate, rencofilstat:
-
ASCEND-NASH: a 12-month Phase 2b clinical trial
clinical trial in biopsy-proven F2/F3 NASH subjects
-
ALTITUDE-NASH: a 4-month Phase 2 liver function
trial in NASH F3 subjects
-
HEPA-CRV431-209: a 4-month Simon Two-Stage Phase
2a study in HCC
The initiation of screening and enrollment in
all three studies is currently expected to begin in the third
quarter of 2022.
“We are very pleased to have been selected to
share both the positive AMBITION study data and our upcoming
clinical trial plans for rencofilstat in NASH and HCC with
clinicians, researchers, and regulators at this prestigious and
clinically focused NASH congress,” said Dr. Hobbs. “The Hepion team
has been hard at work over this past year preparing the clinical
plans for these upcoming trials, and it is exciting to share
details of these trials and look forward to when we soon begin to
enroll subjects for all three.”
A copy of Dr. Hobbs’ presentation is accessible
on the Company’s website at www.hepionpharma.com under
“Publications” in the Pipeline section.
About Hepion
Pharmaceuticals
The Company's lead drug candidate, rencofilstat,
is a potent inhibitor of cyclophilins, which are involved in many
disease processes. Rencofilstat is currently in clinical-phase
development for the treatment of NASH, with the potential to play
an important role in the overall treatment of liver disease - from
triggering events through to end-stage disease. Rencofilstat has
been shown to reduce liver fibrosis and hepatocellular carcinoma
tumor burden in experimental models of NASH, and has demonstrated
antiviral activities towards HBV, HCV, and HDV through several
mechanisms, in nonclinical studies. In November 2021, the U.S. Food
and Drug Administration (“FDA”) granted Fast Track designation for
rencofilstat for the treatment of NASH. That was soon followed in
December 2021 by the FDA’s acceptance of Hepion’s investigational
new drug (IND) application for rencofilstat for the treatment of
hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform,
called AI-POWR™, which stands for Artificial
Intelligence - Precision Medicine;
Omics (including genomics, proteomics,
metabolomics, transcriptomics, and lipidomics);
World database access; and
Response and clinical outcomes. Hepion intends to
use AI-POWR™ to help identify which NASH patients will best respond
to rencofilstat, potentially shortening development timelines and
increasing the delta between placebo and treatment groups. In
addition to using AI-POWR™ to drive its ongoing NASH clinical
development program, Hepion intends to use the platform to identify
additional potential indications for rencofilstat to expand the
company's footprint in the cyclophilin inhibition therapeutic
space.
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; risks associated with delays,
increased costs and funding shortages caused by the COVID-19
pandemic; 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, 2021,
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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