VICTORIA, BC, Sept. 26,
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 grant of a patent
and a notice of allowance for EP-104IAR.
EP-104IAR is the Company's lead product candidate designed to
meet the significant unmet medical need and market demand for
long-lasting pain relief for knee osteoarthritis.
European Patent
The grant of European Patent EP2976062B1 provides compositional
and method of use coverage for EP-104IAR. The patent covers major
European markets of commercial significance.
"The European market represents an important commercial
opportunity for EP-104IAR, and, pending results of the current
Phase 2 clinical development program, the Company intends to
broaden clinical development investments to address the specific
European Union requirements for approval," said Dr. James Helliwell, CEO of Eupraxia. "We believe
the new European patent offers strong protection for EP-104IAR in
key European markets until 2034, pending any adjustments or
extensions."
Brazilian Notice Of
Allowance
The Company also announced today the grant of a Brazilian notice
of allowance, which will provide compositional and method of use
coverage for EP-104IAR. The Company believes this grant will
provide extensive protection for EP-104IAR in the Brazilian market
until 2034, also pending any adjustments or extensions.
"The Brazilian and European intellectual property expansion
demonstrates that the Company continues to fortify its IP around
this high-potential product candidate for knee osteoarthritis,"
added Dr. Helliwell. "Moreover, we believe that this expansion of
our intellectual property could have utility for our broader IP
estate as we evaluate the clinical development of other pipeline
candidates."
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 pain relief for knee osteoarthritis ("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, including the plan for later stage clinical testing and the
commercialization of EP-104IAR; development of additional
intellectual property, ability to patent or otherwise protect such
developed intellectual property; the Company's ability to protect,
expand upon and exploit its existing intellectual property; the
ability of the Company to execute on its business strategy; 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;
non-compliance with regulatory requirements may reduce or eliminate
the Company's patent protection; patent reform legislation in
the United States; legal systems
of some countries do not favour the enforcement of patents and
other intellectual property protection; it may be difficult for the
Company to stop the infringement of the Company's patents or the
misappropriation of other intellectual property rights; proceedings
to enforce the Company's patent rights in foreign jurisdictions
could result in substantial costs and divert the Company's efforts
and attention from other aspects of the Company's business; 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.