VICTORIA,
BC, May 25, 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 reached the last patient last visit in its Phase 2 clinical
trial of EP-104IAR for osteoarthritis ("OA").
Dr. James
Helliwell, CEO of Eupraxia, commented, "Our team has worked
effectively to rapidly advance this study while navigating the
unique challenges of a global pandemic. This is an important
milestone toward the completion of the study, and we remain on
track for top-line data readout in the second quarter of this
year."
Management believes that the top-line data
readout will be well powered and has the potential to demonstrate a
meaningful reduction in OA knee pain with a corresponding
improvement in patient function and an extended duration of effect.
Based on previously released blinded safety data the Company also
believes EP-104IAR has the potential for a best-in-class safety
profile, potentially allowing for bilateral and chronic dosing
regimens.
The Phase 2 trial readout should also offer
important validation of the underlying delivery technology, with
highly tunable kinetics and extended duration of effect. The
Company intends to further exploit this technology in additional
drug candidates.
The Phase 2 trial is a randomized, double blind,
vehicle-controlled study of 300 OA patients with moderate to severe
pain scores as evaluated by Kellgren-Lawrence grade (2-3). The
primary endpoint in the study is the difference in change from
baseline between EP-104IAR and the vehicle control in (Western Ontario and McMaster Universities
("WOMAC") pain score at 12 weeks.
Secondary endpoints include the difference in
change from baseline in WOMAC pain scores continuing to 24 weeks as
well as composite pain/function scores. In addition, the study
supports a significant safety evaluation of the drug including
evaluation of systemic and local toxicity as well as changes in
cortisol levels.
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 timing and potential of top-line data readout; the
ability of the Company to execute on its business strategy; the
potential of Eupraxia's product candidates; the Company's
expectations regarding its product designs, including with respect
to patient benefit, duration, safety and effectiveness; the results
gathered from studies of Eupraxia's product candidates; the
potential for the Company's technology to impact the drug delivery
process; the competitive advantages of the Company's technology;
the benefits to patients from the Company's drug platforms; and the
translation of the Company's technologies and expansion of its
offerings into clinical applications.
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.
For investor and media inquiries, please
contact:
Danielle Egan, Eupraxia
Pharmaceuticals Inc.
778.401.3302
degan@eupraxiapharma.com
or
Adam Peeler, on
behalf of:
Eupraxia Pharmaceuticals Inc.
416.427.1235
adam.peeler@loderockadvisors.com
SOURCE Eupraxia Pharmaceuticals Inc.