--Advisory Board to Provide Guidance for
Company's Eosinophilic Esophagitis Clinical Program--
VICTORIA, BC, May 2, 2024
/CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the
"Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage
biotechnology company leveraging its proprietary DiffuSphere™
technology to optimize drug delivery for applications with
significant unmet need, today announced the formation of a Clinical
Advisory Board for its gastrointestinal ("GI") program. The
Clinical Advisory Board is comprised of Dr. Evan Dellon (Chairman), Dr. Stephen Attwood, Dr. Albert Bredenoord, Dr.
Donna Griebel, Dr. Ikuo Hirano and Dr. Roos
Pouw. The Clinical Advisory Board will work closely with
Eupraxia as it continues its development of EP-104GI for
eosinophilic esophagitis ("EoE"), which is currently in a Phase
1b/2a clinical trial.
"The formation of our Gastrointestinal Clinical Advisory Board
comes at an exciting time for our Company, as we continue to
generate clinical evidence in support of EP-104GI for the treatment
of eosinophilic esophagitis," said Mark
Kowalski, MD, PhD, Chief Medical Officer of Eupraxia. "As we
advance the EoE program, we will now have access to an
extraordinary group of renowned GI experts who will provide key
insights and recommendations to help guide the program toward
advanced stages of clinical development."
"We are delighted to bring together such an impressive group of
experts in the gastrointestinal space," said Dr. James Helliwell, CEO of Eupraxia. "EoE remains a
significant but underserved rare disease with a patient population
that has few therapeutic treatment options. Based on clinical data
generated to date, we believe EP-104GI has shown significant
potential to address this unmet medical need. The formation of our
GI Clinical Advisory Board therefore represents the next logical
step in the evolution of this program and will also play a critical
role as we look to other indications, including benign strictures,
which could present even larger opportunities. We are excited to
have these highly accomplished individuals as advisors, and we look
forward to further expanding our GI Clinical Advisory Board in the
months ahead."
"I am excited to be part of Eupraxia's GI Clinical Advisory
Board at a time when the Company continues to make progress towards
addressing the EoE patient population," said Evan Dellon, MD, MPH. "EoE is a challenging
medical condition that is associated with several allergic
co-morbidities, including allergic rhinitis, asthma, and
IgE-mediated food allergies. Treatments with swallowed
corticosteroids, particularly those traditionally adapted from
asthma preparations, have limited utility due to suboptimal
delivery to the affected area. Eupraxia's technology has shown the
potential to more selectively concentrate drug delivery to the
esophagus, which could significantly improve treatment outcomes for
this patient population."
About the Clinical Advisory Board
Dr. Evan Dellon MD, MPH –
Clinical Advisory Board Chairman
Evan Dellon, MD, MPH, is a
Professor in the Department of Medicine, Division of
Gastroenterology and Hepatology, and adjunct Professor of
Epidemiology at UNC School of Medicine. He has formal research
training in epidemiology, clinical and translational research, and
clinical trial design. He leads and collaborates with
multidisciplinary research teams in the area of esophageal diseases
in general and EoE in particular. His current research, which has
been supported by the National Institute of Health ("NIH") funding,
focuses on optimizing the diagnosis, characterizing the
epidemiology, studying the pathogenesis, and refining the treatment
and monitoring of EoE, with the overall goal of improving patient
care and outcomes in EoE.
Dr. Stephen E. Attwood,
MD
Stephen E. Attwood, MD, FRCSI, is
honorary professor in health services research at Durham University, UK, and an independent
consulting advisor on research and clinical practice for
oesophageal diseases. He qualified from Trinity College Dublin and took his Surgical
Fellowship at the Royal College of Surgeons in
Ireland. Most recently, he was a consultant surgeon at
Northumbria Healthcare UK. Since identifying EoE in 1989 and
publishing the first description of the disease in 1992, Professor
Attwood has spent his career caring for patients with EoE. He
has been actively engaged in clinical trials of upper
gastrointestinal diseases, including budesonide formulations for
EoE; the ASPECT trial of cancer prevention in Barrett's esophagus;
BEST3, a study of Cytosponge screening for Barrett's esophagus in
general practices; the LOTUS trial (surgery vs proton pump
inhibitor for Gastroesophageal Reflux Disease). He has authored
more than 200 publications, including the recent BSG Guidelines on
EoE.
Dr. Albert J. (Arjan)
Bredenoord, MD, PhD
Albert J. (Arjan) Bredenoord, MD,
PhD, is Consultant Gastroenterologist at the Amsterdam University
Medical Center and professor of Neurogastroenterology &
Motility at the University of Amsterdam. Dr. Bredenoord's main focus is on
achalasia, reflux disease and EoE. He is one of the pioneers of
high-resolution manometry and impedance monitoring of the
esophagus. The esophageal clinic in the AMC Amsterdam hosts the
largest population of benign esophageal diseases in the Netherlands. Dr. Bredenoord is an author
of over 250 papers, books and book chapters and organizes regular
courses in Europe, North America and Asia. Dr Bredenoord is President of the
European Society of Eosinophilic Esophagitis, a member of the UEG
Scientific Committee, and co-founder of the International HRM
working group.
Dr. Donna Griebel, MD
Donna Griebel, MD, is a
regulatory consultant with Griebel and Rosebraugh Consulting,
LLC. She retired from the FDA in 2018 after having served as
Division Director of the Division of Gastroenterology and Inborn
Errors Products (with the Office of New Drugs in the Center for New
Drugs and Research ("CDER")) for approximately a decade. Her
prior CDER/FDA leadership roles included Deputy Director of
Division of Reproductive and Urologic Drug Products and Clinical
Team Leader in Division of Oncology Drug Products.
Dr. Ikuo Hirano, MD
Ikuo Hirano, MD, is a Professor
of Medicine at Northwestern University
Feinberg School of Medicine and the Director of the Kenneth C.
Griffin Esophageal Center in the Division of Gastroenterology and
Hepatology. He attended college at Yale
University, medical school at the University of Pennsylvania and completed his
medical residency and GI fellowship at Beth Israel Hospital in
Boston. He is a site principal
investigator for the NIH supported Consortium of Eosinophilic
Gastrointestinal disease Researchers ("CEGIR") and has been
recognized as a Castle Connolly Top Doctor since 2002 and as a
leading esophageal investigator by Expertscape. Dr. Hirano has
written over 250 scientific papers and book chapters on esophageal
and swallowing disorders. He has focused interests on EoE and
eosinophilic gastrointestinal disease and authored several society
guidelines on the management of these increasingly recognized
disorders.
Dr. Roos Pouw, MD, PhD
Roos Pouw, MD, PhD, was born in
Rotterdam, the Netherlands. She
obtained her degree in Medicine at the University of Utrecht and completed a research fellowship at
Harvard Medical School in Boston, after which she started her career in
gastroenterology with a PhD fellowship at the Academic Medical
Centers, Amsterdam, the
Netherlands. After finishing her training in 2017, Dr. Pouw
was appointed staff member at the Dept. of Gastroenterology and
Hepatology at AMC, currently known as the Amsterdam University
Medical Centers. Dr. Pouw has received the United European
Gastroenterology ("UEG") Rising Star award in 2020 for her work
research on endoscopic management of early Barrett's neoplasia. Dr.
Pouw is co-chair of the Young International Society for Diseases of
the Esophagus ("ISDE"), secretary of the Dutch Upper Cancer Group,
national representative for UEG, task force leader for a number of
guideline initiatives and curricula on esophageal neoplasia for the
European Society of Gastrointestinal Endoscopy and ISDE, and
editorial (advisory) board member for the UEG Journal and Best
Practice & Research: Clinical Gastroenterology.
About Eosinophilic Esophagitis (EoE)
EoE is an inflammatory-mediated disease in which white blood
cells migrate into and become trapped in the esophagus, creating
pain and difficulty with swallowing food. It affects more than
180,000 people in the U.S. and has been identified by the American
Gastroenterological Association as rapidly increasing in both
incidence and prevalence. Impacts from both symptoms and
interventions frequently lead to mental health issues, compounding
the disease burden of EoE for both the health care system and the
individual.
About Eupraxia Pharmaceuticals Inc.
Eupraxia is a clinical-stage biotechnology company focused on
the development of locally delivered, extended-release products
that have the potential to address therapeutic areas with high
unmet medical need. The Company strives to provide improved patient
benefit and has developed technology designed to deliver targeted,
long-lasting activity with fewer side effects. DiffuSphere™, a
proprietary, polymer-based micro-sphere technology, is designed to
facilitate targeted drug delivery, with extended duration of
effect, and offers multiple, highly tuneable pharmacokinetic (PK)
profiles. This investigational technology can be engineered for use
with multiple active pharmaceutical ingredients and delivery
methods.
Eupraxia recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for
the treatment of pain due to OA of the knee. The trial met its
primary endpoint and three of the four secondary endpoints.
Eupraxia has expanded the EP-104 platform into gastrointestinal
disease with the Phase 1b/2a RESOLVE
trial for treating EoE. Eupraxia is also developing a pipeline of
later- and earlier-stage long-acting formulations. Potential
pipeline indications include candidates for other inflammatory
joint indications and oncology, each designed to improve on the
activity and tolerability of currently approved drugs. For further
details about Eupraxia, please visit the Company's website at:
www.eupraxiapharma.com.
Notice Regarding Forward-looking Statements and
Information
This news release includes forward-looking statements and
forward-looking information within the meaning of applicable
securities laws. Often, but not always, forward-looking information
can be identified by the use of words such as "plans", "is
expected", "expects", "suggests", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes", "potential"
or variations (including negative and grammatical variations) of
such words and phrases, or state that certain actions, events or
results "may", "could", "would", "might" or "will" be taken, occur
or be achieved. Forward looking statements in this news release
include statements regarding expected benefits from the formation
of the Company's GI Clinical Advisory Board; the Company's product
candidates, including expected benefits to patients; the results
gathered from studies and trials of Eupraxia's product candidates;
the potential for the Company's technology to impact the drug
delivery process; and potential pipeline indications. Such
statements and information are based on the current expectations of
Eupraxia's management, and are based on assumptions, including but
not limited to: future research and development plans for the
Company proceeding substantially as currently envisioned; industry
growth trends, including with respect to projected and actual
industry sales; the Company's ability to obtain positive results
from the Company's research and development activities, including
clinical trials; and the Company's ability to protect patents and
proprietary rights. Although Eupraxia's management believes that
the assumptions underlying these statements and information are
reasonable, they may prove to be incorrect. The forward-looking
events and circumstances discussed in this news release may not
occur by certain dates or at all and could differ materially as a
result of known and unknown risk factors and uncertainties
affecting Eupraxia, including, but not limited to: risks and
uncertainties related to the Company's limited operating history;
the Company's novel technology with uncertain market acceptance; if
the Company breaches any of the agreements under which it licenses
rights to its product candidates or technology from third parties,
the Company could lose license rights that are important to its
business; the Company's current license agreement may not provide
an adequate remedy for its breach by the licensor; the Company's
technology may not be successful for its intended use; the
Company's future technology will require regulatory approval, which
is costly and the Company may not be able to obtain it; the Company
may fail to obtain regulatory approvals or only obtain approvals
for limited uses or indications; the Company's clinical trials may
fail to demonstrate adequately the safety and efficacy of our
product candidates at any stage of clinical development; the
Company may be required to suspend or discontinue clinical trials
due to side effects or other safety risks; the Company completely
relies on third parties to provide supplies and inputs required for
its products and services; the Company relies on external contract
research organizations to provide clinical and non-clinical
research services; the Company may not be able to successfully
execute its business strategy; the Company will require additional
financing, which may not be available; any therapeutics the Company
develops will be subject to extensive, lengthy and uncertain
regulatory requirements, which could adversely affect the Company's
ability to obtain regulatory approval in a timely manner, or at
all; the impact of health pandemics or epidemics on the Company's
operations; the Company's restatement of its consolidated financial
statements, which may lead to additional risks and uncertainties,
including loss of investor confidence and negative impacts on the
Company's common share price; and other risks and uncertainties
described in more detail in Eupraxia's public filings on SEDAR+
(sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted
to identify important factors that could cause actual actions,
events or results to differ materially from those described in
forward-looking statements and information, there may be other
factors that cause actions, events or results to differ from those
anticipated, estimated or intended. No forward-looking statement or
information can be guaranteed. Except as required by applicable
securities laws, forward-looking statements and information speak
only as of the date on which they are made and Eupraxia undertakes
no obligation to publicly update or revise any forward-looking
statement or information, whether as a result of new information,
future events or otherwise.
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SOURCE Eupraxia Pharmaceuticals Inc.