Hepion Pharmaceuticals Announces Initiation of Phase 2b ‘ASCEND-NASH’ Trial
August 31 2022 - 8:00AM
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”), hepatocellular carcinoma
(“HCC”), and other chronic liver diseases, today announced that it
has screened the first subject in the ASCEND-NASH clinical trial.
The trial is being conducted at up to 121 sites in seven countries,
with 85 of the sites located within the U.S.
ASCEND-NASH is a Phase 2b, randomized,
multi-center, double-blinded study to evaluate the safety and
efficacy of rencofilstat in 336 subjects dosed for 12 months.
Subjects included in the trial will be either F2 or F3
biopsy-confirmed, with enrollment of F3 subjects of at least 60%,
to focus on NASH subjects with more advanced fibrosis. Subjects
will receive either placebo or rencofilstat, administered orally
once daily at doses of 75, 150, or 225 mg (n=84 subjects/cohort).
Endpoints will evaluate improvements in both fibrosis and
steatosis, with the overall study primary endpoint being an
improvement of fibrosis score by one point without a worsening of
steatosis, or an improvement of steatosis without worsening of
fibrosis. Although the main trial endpoint is histologic and
determined by changes in the biopsy, numerous other non-invasive
markers (“NIM”) will be assessed, including NASH efficacy
biomarkers, magnetic resonance elastography (“MRE”), and multiomics
(e.g. proteomics and transcriptomics).
“ASCEND-NASH represents the first time that
rencofilstat is being studied in a biopsy confirmed-trial,”
commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “We
anticipate full enrollment in 12-to-14 months, as this is a large
and rigorously controlled trial with a 60-day screening period
including multiple laboratory analyses, Fibroscan evaluation, liver
biopsy, and MRE. We will also be following the U.S. Food and Drug
Administration-recommended utilization of a three-panel consensus
to read all liver biopsies. As the study advances, our independent
Data and Safety Monitoring Board will conduct two interim analyses.
The first review will occur when one-third of study subjects have
passed the six-month evaluation, and the second DSMB review will
occur when one-third of subjects have completed the study and have
had a final biopsy. Additionally, we received Fast Track
designation from the FDA in November of 2021; this allows for the
submission of study reports as they are obtained, as well as more
frequent engagement with the Agency, which should provide for
smoother transition from Phase 2b to Phase 3.”
“Initiation of screening in our Phase 2b
ASCEND-NASH clinical trial represents a significant step forward
for our company,” stated Robert Foster, PharmD, PhD, Hepion’s Chief
Executive Officer. “For quite some time, our team has been busy
setting the stage for this major clinical trial. Our efforts have
focussed on ongoing optimization of drug manufacturing and product
formulation; packaging; qualification of trial sites; and
engagement with contract research organizations and regulatory
agencies around the world. While these activities are time- and
resource-intensive, it is gratifying to now see them culminate in
the initiation of subject screening.”
Dr. Foster continued, “Finally, our goal is to
create an ecosystem built around rencofilstat as the core asset. To
that end, we are utilizing our proprietary AI-POWR™ tools to
explore ways to create companion diagnostics to help identify which
subjects may best respond to rencofilstat. We anticipate this
approach of bundling rencofilstat with companion diagnostics will
be advantageous when conducting future clinical trials, and
developing a commercial strategy.”
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 followed in June
2022 by the FDA’s granting of Orphan Drug designation to
rencofilstat for the treatment of 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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