-- Clean Safety Review from Data Safety
Monitoring Board Supports Addition of Diabetes Patients into the
Trial --
VICTORIA,
BC, Oct. 11, 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
updates to its Phase 2 trial which is evaluating EP-104IAR's
efficacy and safety for the treatment of osteoarthritis ("OA") of
the knee.
"A clean safety review from our Data Safety
Monitoring Board has increased our confidence in EP-104IAR's
potential as a treatment for OA of the knee and has allowed us to
expand the scope of our Phase 2 trial," said Dr. James Helliwell, CEO of Eupraxia. "The updates
we are announcing today have the potential to generate more robust
data that could support a stronger Phase 3 trial for EP-104IAR, and
further differentiate the product candidate's commercial profile in
the longer-term. In addition, we believe that these updates
increase EP-104IAR's opportunity to become an effective chronic
treatment for a chronic disease. More than ever, we are excited
about EP-104IAR's potential to treat OA, a disease with limited
safe and effective treatment options that affects more than 30
million people in the U.S. alone."
Updates to the Company's Phase 2 trial
include:
Completion of Data Safety
Monitoring Board ("DSMB") Reviews
Eupraxia announced today that its ongoing Phase 2
study has successfully completed all DSMB reviews, with no
drug-related Serious Adverse Events noted, and a clean safety
profile.
Inclusion of Patients with
Diabetes as an Important Subgroup
The Company also announced today that based on
the clean safety profile observed during the Data Safety Monitoring
Board Review, it is now including patients with a diabetes
diagnosis in its Phase 2 trial. Diabetics represent a meaningful
percentage of patients diagnosed with OA, and inclusion of this
important subgroup will provide valuable additional data to guide
further drug development.
Inclusion of Magnetic Resonance
Imaging in the Trial's Protocol
Magnetic Resonance Imaging ("MRI") has been added
to the trial's protocol to further characterize the safety profile
of EP-104IAR and could strengthen EP-104IAR's differentiation as a
treatment for OA. This elective imaging component is expected to
help identify EP-104IAR-induced reductions in inflammation and
assess ongoing cartilage health in patients. Scans will follow
patients at zero, three, six and 12 months, with a potential to
include up to 50 patients. This change was implemented after the
DSMB meeting and in conjunction with strong supportive pre-clinical
evidence of cartilage health and joint health. The Company believes
this MRI subgroup may further strengthen the pre-clinical data seen
to date.
The Company also anticipates that this data will
better inform its evaluation for inclusion of imaging in its
planned Phase 3 program with the drug.
Dr. Helliwell commented, "We believe that a
detailed visual representation of EP-104IAR's effect on knee
osteoarthritis inflammation and joint morphology could be valuable
in informing our Phase 3 trial design, and, on a longer-term basis,
could better support physician decisions to prescribe the drug
should it reach the commercial stage."
As a cumulative result of the updates to its
Phase 2 trial, the Company anticipates that top-line data from the
study will now be available in the second quarter of 2023. Eupraxia
previously anticipated that the top-line data would read out in the
first quarter of 2023.
About EP-104IAR
Eupraxia's lead product candidate, EP-104IAR, 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-104IAR, 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-104IAR 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 patented
technology platform.
Injected into the knee, EP-104IAR 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-104IAR 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.
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
OA of the knee. In addition to EP-104IAR, Eupraxia is developing a
pipeline of earlier-stage long-acting formulations. Potential
pipeline candidates include a range of drugs for indications such
as postsurgical pain (EP-105), and post-surgical site infections
(EP-201), each designed to improve on the activity and tolerability
of 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 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 clinical
trial; the expected timing and potential of data to support and
inform a planned Phase 3 trial; the ability of the Company to
execute on its business strategy; the expected benefits of using
MRI; the expansion of patient enrollment in the Company's Phase 2
clinical trial; the inclusion of diabetics in the Company's Phase 2
trial; the potential of Eupraxia's product candidates, including
EP-104IAR'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 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; 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.