Hepion Pharmaceuticals Schedules Conference Call to Review Topline Results from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat
20 5월 2023 - 5:05AM
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
fibrotic diseases, including non-alcoholic steatohepatitis
(“NASH”), hepatocellular carcinoma (“HCC”), and other chronic
diseases, today announced that it expects to release topline
results from the Phase 2 ALTITUDE-NASH clinical trial before the
market opens on Monday, May 22, 2023.
Hepion is pleased to invite all interested
parties to participate in a conference call at 8:30 a.m. ET on May
22, during which the ALTITUDE-NASH topline results will be
discussed. To participate in this conference call, please dial
(800) 715-9871 (U.S.) or (646) 307-1963 (international), conference
ID 9439742, approximately 10 minutes prior to the start time. The
call will also be broadcast live and archived on the Company's
website at www.hepionpharma.com under "Events" in the Investors
section.
About ALTITUDE-NASH
ALTITUDE-NASH, a Phase 2, randomized,
multi-center, open-label study, enrolled 70 subjects classified as
NASH stage F3 based on either historical biopsy or by using the
AGILE 3+ criteria, defined by a screening Fibroscan score alongside
common clinical and laboratory parameters. The study was designed
to evaluate the safety and efficacy of rencofilstat on hepatic
function and numerous NASH biomarkers after four months of dosing.
Subjects were randomized to receive a once daily, oral dose of 75,
150, or 225 mg rencofilstat soft gelatin capsules (20 subjects in
each dosing cohort). The HepQuant ‘SHUNT’ test, a measure of
hepatic function, was performed at baseline, and changes in the
Disease Severity Index (“DSI”) score relative to baseline
measurements were determined at days 60 and 120. Other NASH
biomarkers were collected throughout the study duration.
About Hepion
Pharmaceuticals
The Company’s lead drug candidate, rencofilstat,
is a potent inhibitor of cyclophilins, which are involved in many
disease processes. Rencofilstat has been shown to reduce liver
fibrosis and hepatocellular carcinoma tumor burden in experimental
disease models and is currently in Phase 2 clinical development for
the treatment of NASH. 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 observable differences 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
StatementsCertain 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, 2022,
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
Hepion Pharmaceuticals (NASDAQ:HEPA)
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