Full Press Release Details
Eupraxia Pharmaceuticals Announces
Gastrointestinal Clinical Advisory Board
- Advisory Board to Provide Guidance for Company's
Eosinophilic Esophagitis Clinical Program -
Victoria, B.C. - May 2, 2024 -
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,
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.
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 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
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
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