Hepion Pharmaceuticals Announces Poster Details for the Upcoming AASLD The Liver Meeting® 2021
November 10 2021 - 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”) and other liver diseases,
today announced that results from its Phase 2a ‘AMBITION’ NASH
trial will be available as an e-poster at the Liver Meeting® 2021,
hosted by the American Association for the Study of Liver Diseases
(AASLD), to be held virtually November 12-15, 2021.
Poster Details
- Poster
#: 1872
-
Title: Investigating CRV431 in NASH Patients: Data
from the Phase 2a AMBITION Study
-
Session: 2304 - NAFLD AND NASH: EXPERIMENTAL:
CLINICAL
- Lead
Author: Stephen Harrison, MD, Medical Director for
Pinnacle Clinical Research, San Antonio, Texas, and Visiting
Professor of Hepatology, Oxford University.
The meeting platform with posters is now open
and the e-poster is also available on the publications page of the
Company’s website.
About the Phase 2a AMBITION Clinical
Trial
AMBITION, a multicenter, randomized, placebo
controlled, single-blind Phase 2a trial, enrolled 43 NASH patients.
The trial was designed to investigate once daily oral
administration of CRV431 at doses of 75 mg (n=12) and 225 mg (n=17)
administered as soft gelatin capsules to presumed F2 and F3 NASH
subjects for 28 days, followed by a 14-day observation period for
safety.
All primary endpoints of the AMBITION NASH trial
(safety, tolerability and pharmacokinetics) were met, and changes
in select biomarkers indicated efficacy of CRV431.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a
potent inhibitor of cyclophilins, which are involved in many
disease processes. CRV431 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. CRV431 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.
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 CRV431, 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 CRV431 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, 2020,
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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