- Company remains on track for Phase 2 data
readout in Q2 2023 -
VICTORIA, BC, Dec. 7, 2022
/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 completed enrollment, randomization and
dosing of the last patient, in its Phase 2 trial that is evaluating
the efficacy and safety of EP-104 for the treatment of
osteoarthritis ("OA") of the knee.
"Eupraxia has successfully achieved another important clinical
milestone in our ongoing Phase 2 trial, removing patient accrual
risk by dosing our last patient," said Dr. James Helliwell, CEO of Eupraxia. "The entire
team has worked tirelessly to fully enroll the study during a time
when many biotech companies are facing challenges enrolling trials.
With this important step behind us, we remain confident in our
ability to report top-line trial results in the second quarter of
2023."
The trial's primary endpoint is the difference in change from
baseline between EP-104 and placebo in the Western Ontario and McMaster Universities
Osteoarthritis Index ("WOMAC") pain subscale at 12 weeks, with a
key secondary endpoint at 24 weeks. Additional key secondary
endpoints include the difference in change from baseline between
EP-104 and placebo in the WOMAC function subscale.
A magnetic resonance imaging ("MRI") sub-study was also added to
the trial's protocol late in the enrollment period to further
characterize the safety profile of EP-104 and potentially
strengthen EP-104's differentiation as a treatment for
OA.
Eupraxia also continues to advance its ongoing Phase
1b/2a trial evaluating EP-104's
safety and efficacy as a treatment for eosinophilic
esophagitis ("EoE"), with data from the trial expected to begin
reading out in the first half of 2023.
About EP-104
Eupraxia's lead product candidate, EP-104, is designed to meet
the significant unmet medical need and market demand for
long-lasting disease relief in multiple indications benefitting
from highly localized and longer delivery of corticosteroids. The
lead indication is for pain relief in knee OA. The U.S. Centers for
Disease Control and Prevention estimates that knee OA affects more
than 30 million people in the U.S. alone. This includes 14 million
that suffer with knee pain or some form of disability. Knee OA is
also associated with depression and loss of sleep, which can
greatly affect quality of life.
With EP-104, Eupraxia hopes to change the way knee OA pain is
treated. Current therapies are challenged by poor safety,
inadequate efficacy and/or limited duration of activity.
Corticosteroids are one of only two drug classes strongly
recommended by the American College of Rheumatology and the
Arthritis Foundation for the treatment of knee OA pain. Currently
approved corticosteroids are very effective at reducing pain for a
short duration late in the disease but can expose the body to
unwanted local and systemic side effects.
EP-104 endeavours to provide long-term pain relief with fewer
unwanted side effects. It encapsulates a highly potent
corticosteroid (fluticasone propionate) within a microns-thin
polymer membrane, part of Eupraxia's proprietary technology
platform.
Injected into the knee, EP-104 is intended to diffuse drug
slowly into the knee joint providing therapeutic concentrations for
up to six months. This has the potential dual advantage of
providing long-duration pain relief with fewer systemic side
effects. An enhanced safety profile would also benefit the
estimated 70% of knee OA patients that experience pain in both
knees by allowing simultaneous treatment of both affected
joints.
In contrast to immediate release steroids, a non-clinical study
of EP-104 suggests a cartilage sparing effect, which could provide
a safer treatment alternative for those afflicted with chronic OA
pain. The product has also been designed with physician convenience
in mind – targeting a long shelf life, no refrigeration and easy
integration into existing delivery techniques.
The potential advantages of EP-104 are central to the expansion
into EoE and other indications. EoE is a localized inflammatory
disease of the esophagus that has relied primarily on swallowing
steroids (often off-label compounded versions) to control disease
symptoms. Eupraxia hopes that a localized administration of an
extended-release steroid will offer patients an effective treatment
option that lasts for months instead of hours.
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-104, 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",
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state that certain actions, events or results "may", "could",
"would", "might" or "will" be taken, occur or be achieved. Forward
looking statements in this press 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 and
Phase 1b/2a clinical trials,
including the expected timing of data readout from the trials; the
ability of the Company to execute on its business strategy; the
potential benefits of using MRI; the potential of Eupraxia's
product candidates, including EP-104's potential to treat OA; the
Company's expectations regarding its product designs, including
with respect to targeted shelf life, storage, ease of integration,
duration, effectiveness and safety; 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; the translation of the
Company's technologies and expansion of its offerings into clinical
applications; the Company's estimation of potential product
markets; and the demand and market acceptance for products
developed by the Company. 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 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.