VICTORIA, BC, May 18, 2023
/CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the
"Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology
company with an innovative drug delivery technology platform, today
announced that it has appointed Mark
Kowalski, MD, PhD, as the Company's Chief Medical Officer
("CMO"), effective May 18, 2023.
Dr. James Helliwell, CEO of
Eupraxia said, "Mark is an accomplished clinical leader with more
than two decades of experience in global clinical development and
regulatory strategy. As we approach our Phase 2 readout with
EP-104IAR in osteoarthritis, expected in the second quarter of this
year, together with the broadening of our pipeline with additional
drug candidates, the need for an experienced CMO has become
compelling. We are pleased to attract a candidate of Dr. Kowalski's
calibre to this critical role and welcome Mark to the team."
"I am excited about the prospects of Eupraxia's lead candidate
EP-104IAR in osteoarthritis and the broader utility of the
underlying technology platform," said Dr. Kowalski. "This is an
exciting time to be joining the Company and I look forward to
working with the team as we advance this technology in the clinic
and potentially through to commercialization."
Dr. Mark Kowalski
Background
Dr. Kowalski has more than 20 years of experience in the
pharmaceutical and biotech industry. He is a clinical leader,
developing regulatory strategy and global clinical development
plans for a variety of product types including small molecules,
biologics (monoclonals, immunoconjugates, siRNAs) and vaccines,
while working in a range of indications, including oncology,
infectious diseases, urology, analgesia, allergy, rheumatology and
metabolic disorders.
He brings to Eupraxia experience with clinical study design,
database design and authoring protocols for Phase 1 through 3
clinical trials, as well as medical monitoring and
pharmacovigilance services for Phase 1 through 4 clinical trials,
plus data analysis and writing of clinical study reports.
Dr. Kowalski held multiple senior roles, including Chief Medical
Officer, at Sierra Oncology, a public company acquired by GSK plc
in 2022 for US$1.9 billion.
Prior to that, he was the Chief Medical Officer and Senior Vice
President at Arbutus Biopharma, a biotechnology company devoted to
discovering and developing a cure for chronic Hepatitis B.
Before that, he held the same position at Tekmira, a
biopharmaceutical company focused on developing therapeutics based
on RNA interference utilizing lipid nanoparticle delivery
technology in oncology, infectious disease, metabolic and other
clinical indications.
Prior to Tekmira, Dr. Kowalski worked in the oncology and
inflammation therapeutic area at Gilead Sciences, Inc. following
Gilead's US$510-million acquisition
of YM BioSciences Inc., at which Dr. Kowalski had been CMO and Vice
President of Regulatory Affairs.
Dr. Kowalski holds a B.A. from Rutgers
University and an M.D. and Ph.D. from the University of Kansas School of Medicine. He
completed his postgraduate training in internal medicine and
infectious diseases at Duke University
and Harvard Medical School and is
Board-certified in both.
About Eupraxia Pharmaceuticals
Inc.
Eupraxia is a clinical-stage biotechnology company focused on
the development of locally delivered, extended-release alternatives
to currently approved drugs. Each of Eupraxia's product candidates
has the potential to address therapeutic areas with high unmet
medical need and strives to provide improved patient benefit by
delivering targeted, long-lasting activity with fewer side
effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in
Phase 2 development for the treatment of pain due to osteoarthritis
of the knee. The EP-104 platform has expanded into gastrointestinal
disease with the launch of a Phase 1b/2a program to treat eosinophilic esophagitis.
Eupraxia is also developing a pipeline of later- and earlier-stage
long-acting formulations. Potential pipeline indications include
candidates for both 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 Canadian
securities laws. Often, but not always, forward–looking information
can be identified by the use of words such as "plans", "is
expected", "expects", "scheduled", "intends", "contemplates",
"anticipates", "believes", "proposes" 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 the Company's business strategies and objectives,
including current and future plans and opportunities, expectations
and intentions; statements regarding the Company's Phase 2 clinical
trials; the anticipated timing for data readout; the expectations
regarding Dr. Kowalski and his role as Chief Medical Officer; the
potential of Eupraxia's product candidates; the Company's
expectations regarding its product designs, including with respect
to patient benefit, duration and effectiveness; and the Company's
expectations regarding the potential and advancement of its
technology.
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: 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 the COVID-19
pandemic on the Company's operations; and other risks and
uncertainties described in more detail in Eupraxia's public filings
on SEDAR (www.sedar.com). 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.
SOURCE Eupraxia Pharmaceuticals Inc.