Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma
(“HCC”), today announced the appointments of Anand Reddi, M.S., and
Kaouthar Lbiati, M.D., to its Board of Directors, effective
immediately.
“We are thrilled to welcome individuals of this
caliber to our Board,” said Hepion’s Chairman, Gary S. Jacob, Ph.D.
“Mr. Reddi and Dr. Lbiati have a remarkable wealth of experience
across all aspects of drug development, from clinical research to
medical affairs, marketing, market access and patient advocacy.
Their combined expertise comes at an opportune time, as we are in
final preparations to advance our lead drug candidate,
rencofilstat, into three Phase 2 clinical trials, and are beginning
to actively explore partnering and licensing opportunities for this
liver-targeting, orally administered, novel cyclophilin
inhibitor.”
Appointment of Anand Reddi
Mr. Reddi has an accomplished history, spanning
a variety of activities including corporate strategy, strategic
partnerships, R&D strategy, investor relations, corporate
affairs, medical affairs, international commercial operations,
global marketing, market access and patient advocacy during his
time in the global biopharmaceutical industry. He is currently Vice
President of Corporate Strategy and External Affairs &
Engagement, as well as Chief of Staff at Adverum Biotechnologies, a
clinical-stage gene therapy company targeting unmet medical needs
in ocular and rare diseases. Prior to joining Adverum, Mr. Reddi
held strategic and operational leadership positions of increasing
responsibility during his seven-year career at Gilead Sciences,
most recently serving as Director and Head, Digital Innovation
Customer Engagement. At Gilead, Mr. Reddi was instrumental in
establishing international access and emerging markets initiatives
in over 140 countries for the HIV medicines Truvada®, Descovy®,
Genvoya® and Biktarvy®; hepatitis B treatments Viread® and
Vemlidy®; and the hepatitis C cures Sovaldi®, Harvoni®, Epclusa®
and Vosevi®; resulting in over 20 million patients with access to
these treatments in resource limited settings. Previously, he was
active in HIV/AIDS global health policy, basic science and clinical
research focused on bone tissue engineering, and skin cancer
metastasis and signal transduction.
Mr. Reddi has authored or co-authored more than
20 peer-reviewed articles in scientific journals such as Science,
Nature Biotechnology, JAMA Pediatrics, and AIDS; written op-eds for
several major media outlets, such as The Washington Post and The
New York Times; and is a featured blogger on The Huffington Post.
He holds a Master of Science degree from the University of Colorado
School of Medicine, where he studied medicine. He received a
Bachelor of Arts degree in history and a Bachelor of Science degree
in biology from the University of Michigan. In addition, Mr. Reddi
has the distinction of serving as a J. William Fulbright Scholar in
South Africa.
Mr. Reddi commented, “I am honored to join the
Hepion Board particularly as the Company is at the stage where its
clinical program is maturing, and its activities are increasingly
encompassing those areas of interest I believe I will be able to
most impact. What excites me most about Hepion is the great
potential of the Company’s lead drug to benefit the millions of
people suffering from chronic liver disease, including NASH and
HCC. I believe my extensive experience in biopharma strategy and
operations, as well as dealing with global public health issues,
will make an impact as we move forward with the development of
rencofilstat as a potential transformational medicine and bring
value to patients, physicians, and health care systems.”
Appointment of Dr. Kaouthar
Lbiati
Dr. Lbiati is a multi-functional executive with
a combination of scientific, business, finance, global health
policy, and health economics skills. She is currently Vice
President, Strategy & Corporate Development at Cytovia
Therapeutics, a biopharmaceutical company specializing in
immuno-oncology and cell therapies. Dr. Lbiati previously served in
global and regional leadership roles at Amgen, Glaxo Smith Kline,
and Sanofi, where she supported the registration, launch and/or
indication extension and reimbursement of three innovative cancer
drugs – Blincyto®, Jevtana® and Votrient® – in the U.S., EU and
MENA regions, with a focus on global medical affairs; strategic
planning, health economics and outcomes research; and market access
across multiple countries. Most recently, Dr. Lbiati has served as
a strategic advisor to several biotech companies and venture
capital firms. She headed the portfolio strategy at Steba Biotech
(a radio-pharmaceutical and oncology company); served as a medical
technology investment consultant to Forepont Capital Partners; and
was Director, Strategic Market Access at Amaris, a global
pharmaceutical consulting company.
Dr. Lbiati received a Doctor of Medicine degree
from Rabat, Morocco’s Mohammed V University, a fellowship in
oncology from the Gustave Roussy Institute in Paris, a Specialized
Executive Master’s degree in Strategy & Management from ESSEC
Business School in Paris, and a Master of Science in International
Policy and Health Economics from the London School of
Economics.
“I am pleased to be joining the Hepion Board at
this momentous time, as I believe Hepion’s rencofilstat has the
potential to become an important new treatment for NASH and HCC,
and the Company is in the midst of preparing this promising
candidate for Phase 2 trials in both indications,” commented Dr.
Lbiati. “One of the key elements as the Company moves forward with
further clinical development of rencofilstat will involve strategic
issues that have been a keen interest of mine throughout my career.
I look forward to contributing to the work of the Board and
Hepion’s pioneering management team as we continue to advance
rencofilstat’s development program.”
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 impact
the overall course of disease at various stages, 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). In June 2022, rencofilstat was
granted Orphan Drug designation by the FDA 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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