VICTORIA, BC, June 8, 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 commenced dosing patients in its phase
1b/2a trial that is evaluating
EP-104GI's safety, tolerability and efficacy as a treatment for
eosinophilic esophagitis ("EoE").
"Dosing the first patient in our EoE trial is a significant
achievement for the Company's clinical team and an important step
towards realizing the therapeutic potential of this product
candidate for a condition with significant unmet medical need,"
said Dr. James Helliwell, CEO of
Eupraxia. "We are excited to move this program forward rapidly and
establish proof of concept in patients this year. Given that this
is an open-label study, we expect to begin reporting results by
cohort in the second half of 2023. Together with our phase 2 study
of EP-104IAR in osteoarthritis of the knee, we expect to report a
meaningful volume of mid-stage clinical data for our product
candidate across two indications in 2023."
EoE is a chronic, immune-mediated condition of the esophagus
that causes inflammation, structural damage and dysfunction when
left untreated. It is characterized as an "orphan disease" – a rare
condition that affects fewer than 200,000 people in the United States, and for which exists
significant unmet medical need.
Current EoE Treatment
Options
Current EoE treatment options, which include diet changes,
proton pump inhibitor therapy, slowly dissolving oral steroid
tablets, monoclonal antibodies, and/or mechanical endoscopic
dilation, often provide poor or temporary control over the
condition.
Oral administration of steroids, including fluticasone
propionate, can provide short-term relief. But prolonged use of
these formulations, often prescribed off-label, can lead to other
conditions such as candidiasis (thrush) in the mouth and esophagus,
and ultimately poor patient compliance and disease control.
EP-104's Potential
Differentiation
EP-104 represents an opportunity to inject long-acting
fluticasone propionate directly into the affected tissues of a
patient's esophagus utilizing the Company's drug delivery
technology platform, with the potential for extended duration of
effect, optimized drug kinetics and an improved safety profile.
The Company's technology platform, which encapsulates
fluticasone propionate, uses a novel polymer membrane designed to
release drug at a pre-defined rate and could result in an
effective, sustained treatment for EoE, improving patient
outcomes.
Phase 1b/2a Trial Details
- Eupraxia's phase 1b/2a trial for
EoE is an open-label, single ascending-dose study assessing
patients one and three months post treatment.
- The trial's target enrollment is up to 15 patients enrolled
from centres in Canada,
the Netherlands and Australia.
- 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 EoE trial will begin with a low-dose cohort to assess
pharmacokinetics of the delivery methodology. As the trial
progresses, escalating doses may be given in subsequent cohorts to
optimize patient outcomes, identify duration of the treatment and
assess safety.
- The trial's primary endpoint is a clinically significant
reduction of eosinophils, which are specialized white blood cells
that curb infection and boost inflammation. The trial will also
assess the functional improvement of patients with EoE.
- Eupraxia intends to pursue orphan drug status and any other
mechanisms that could accelerate clinical testing and regulatory
submission for EoE.
Eupraxia also continues to advance its ongoing phase 2 trial
evaluating EP-104IAR's safety and efficacy as a treatment
for knee osteoarthritis ("OA") and expects to report top-line
trial results in the second quarter 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, such
as EoE and OA.
EP-104 is comprised of a highly potent corticosteroid
(fluticasone propionate) within a microns-thin polymer membrane,
part of Eupraxia's patented technology platform.
Many drugs have the potential to work well but are limited by
the way they are delivered. This can lead to unwanted side effects,
poor efficacy, and a short duration of action.
Eupraxia's polymer-based proprietary technology aims to provide
better therapy by potentially delivering the right dose of drug, in
the right place, for the right amount of time.
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-104 platform has expanded into gastrointestinal
disease with the launch of a phase 2 program to treat EoE. 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", "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 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
1b/2a trial, including assessment
objectives and expected timing with respect to the reporting of
results and trial completion; the anticipated dosage used in the
phase 1b/2a trial; the Company's
intention to pursue orphan drug status or other mechanisms;
statements regarding the Company's phase 2 trial, including ongoing
advancement and expected timing with respect to the reporting of
results; the potential of Eupraxia's product candidates, including
EP-104's potential to treat EoE and OA and its differentiation from
other drugs; the Company's expectations regarding its product
designs, including with respect to targeted shelf life, storage,
ease of integration, duration, tolerability, 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; 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 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.