-Represents second Phase 2 program for EP-104IAR,
with initial data readout anticipated in H1, 2023-
VICTORIA, BC, Oct. 12,
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 the initiation of a
Phase 2 trial of EP-104IAR in adult patients afflicted with
eosinophilic esophagitis (EoE), a rare disease that restricts the
ability to swallow food and greatly impacts quality of life.
"EP-104IAR is designed to precisely deliver therapeutic levels
of injected fluticasone propionate over an extended duration, which
may help overcome some of the limitations of traditional oral
steroids and provide longer and more stable disease remission and
an improved quality of life for patients with EoE," said Dr.
James Helliwell, CEO of
Eupraxia. "On that basis, we are initiating a Phase 2,
open-label clinical study in adult patients with data from the
trial expected to begin reading out in the first half of 2023."
The Company believes its drug delivery technology platform has
the potential to be effective in EoE based on the proven
efficacy of oral immediate release fluticasone propionate in this
indication, and the growing library of data supporting the value of
extended-release steroids in a variety of indications. The
Company's technology is underpinned by a novel polymer membrane
designed to release drug at a pre-defined rate, which could result
in an effective, sustained treatment for EoE, improving patient
outcomes.
Eupraxia has received regulatory clearance in Canada and the
Netherlands, with responses pending from additional
jurisdictions. The Company believes that this expansion of its
clinical-stage pipeline represents the opportunity to further
demonstrate the value of its platform across multiple indications.
Eupraxia is continuing to pursue additional drug candidates and
therapeutic targets, with a specific focus in oncology.
About EoE
EoE is a chronic, immune mediated condition of the esophagus
that causes inflammation, structural damage and dysfunction. It is
characterized as an "orphan disease" – a rare condition that
affects fewer than 200,000 people in the
United States and/or 5 in 10,000 Europeans, and for which
exists significant unmet medical need.
Current EoE treatment options (including diet changes, drugs
such as proton pump inhibitors designed to help block acid
build-up, and topical steroids that are swallowed to help reduce
swelling and inflammation, and surgical dilation) often provide
poor or only temporary control over the condition. Oral
administration of steroids, including fluticasone propionate, can
provide short-term relief, but prolonged use of these formulations,
which are often prescribed off-label, leads to other conditions,
such as candidiasis (thrush) in the mouth and esophagus, and
ultimately poor patient compliance and disease control. In
contrast, EP-104IAR poses the opportunity to inject long-acting
fluticasone propionate directly into the affected tissues, with the
potential for extended duration of effect, optimized drug kinetics
and an improved safety profile.
Clinical Strategy
EP-104IAR is currently being evaluated in a multi-centre
European Phase 2 study focused on patients with osteoarthritis of
the knee. This program includes significant and on-going
pre-clinical data on EP-104IAR, allowing the EoE Phase 2 study to
commence immediately in patients. The EoE study will assess the
safety, tolerability and potential efficacy of endoscopically
targeted injections of fluticasone propionate into affected areas
of the esophagus. The Phase 2 trial in EoE will begin with a low
dose to assess to pharmacokinetics of the delivery methodology. As
the trial progresses, escalating doses may be given to optimize
patient outcomes and duration of the treatment. The study will be
conducted in multiple jurisdictions, including Canada and the
Netherlands.
Eupraxia intends to pursue orphan drug status and any other
mechanisms that could accelerate clinical testing and ultimate
regulatory submission for EoE.
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.
The potential advantages of EP-104IAR 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-104IAR, is currently in
Phase 2 development for the treatment of pain due to OA of the
knee. The EP-104IAR platform is expanding into gastrointestinal
disease with the launch of a program to treat EoE. 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", "potential" 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 Phase 2 trial of EP-104IAR in patients afflicted with
EoE, including the expected outcome of the Phase 2 trial, the
expected timing of data from the Phase 2 trial and the receipt of
regulatory clearance from additional jurisdictions; the potential
and potential benefits of EP-104IAR; 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 ability of the Company
to execute on its business strategy; the Company having sufficient
resources, including anticipated funding from its current cash
runway; the potential of Eupraxia's product candidates; the
Company's expectations regarding its product designs, including
with respect to targeted shelf life, storage and ease of
integration; 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.