VICTORIA, BC, June 13,
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 the U.S. Food
and Drug Administration ("FDA") has granted Fast Track designation
for the investigation of EP-104IAR in the treatment of adults with
osteoarthritis ("OA") of the knee.
The Fast Track process is designed to facilitate the development
and expedite the review of drugs that treat serious conditions and
fill an unmet medical need. Fast Track designation does not change
the FDA standard for approval and is intended to provide more
frequent interactions with the FDA to help facilitate the
regulatory approval process.
"Being granted Fast Track designation for EP-104IAR is another
important step for our clinical development program," said Dr.
James Helliwell, CEO of Eupraxia.
"OA affects millions of people in the
United States and most of these people have limited options
to manage their symptoms."
Eupraxia continues to advance its ongoing Phase 2 trial
evaluating EP-104IAR's safety and efficacy as a treatment candidate
for knee OA and expects to report top-line data results in the
second quarter of 2023.
About EP-104IAR and OA
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 knee OA affects more than
30 million people in the U.S. alone1. This includes 14
million that suffer from knee pain or some form of
disability2. Knee OA is also associated with depression
and loss of sleep, which can significantly affect quality of
life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is
treated. Current therapies are often associated with limited
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 treating
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 has the potential to provide longer 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 designed to diffuse drug
slowly into the knee joint providing therapeutic
concentrations for up to six months. This has the
potential dual advantage of providing a longer duration of pain
relief with fewer systemic side effects. By reducing systemic side
effects, it has the potential to benefit the estimated 70% of knee
OA patients that experience pain in both knees by allowing
simultaneous treatment of both affected joints. The Company
believes that other potential benefits of this product candidate,
if approved, include a long shelf life, no requirement for
refrigeration and easy integration into existing delivery
techniques.
1.
|
Osteoarthritis Fact
Sheet. Centers for Disease Control and Prevention. Available at
www.cdc.gov/arthritis/basics/osteoarthritis.htm. January 10,
2019.
|
2.
|
Vina, E.R.; Kwoh, C.K.
Epidemiology of osteoarthritis: literature update. Curr Opin
Rheumatol. 2018, 30(2):160 – 167. DOI:10.1097/BOR.0000000000000479.
("Vina & Kwoh 2018").
|
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 Eupraxia 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 program to treat eosinophilic
esophagitis, or 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 ongoing clinical
trials and pipeline development, including assessment objectives
and expected timing with respect to the reporting of results and
trial completion; the anticipated dosage used in any ongoing trial;
the Company's intention to pursue orphan drug status or other
regulatory 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 potential benefits, 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; the
translation of the Company's technologies and expansion of its
offerings into clinical applications; and potential benefits of the
Company's Fast Track designation, which may or may not facilitate
regulatory approval. 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.