- Decision to proceed with Phase 3 follows completion of
End-of-Phase 2 meeting with the U.S. FDA
VICTORIA, BC, Feb. 1, 2024
/CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the
"Company") (TSX: EPRX), a clinical-stage biotechnology company
leveraging its proprietary Diffusphere™ technology to optimize drug
delivery for applications with significant unmet need, today
announced the Company has initiated its Phase 3 development program
for EP-104IAR, the Company's lead drug candidate for the treatment
of osteoarthritis ("OA") of the knee, following completion of its
End-of-Phase 2 meeting with the U.S. Food & Drug Administration
("the FDA").
Based on this interaction, the Company anticipates it is on
track to dose the first patient in its Phase 3 program in the third
quarter of 2024.
The recent End-of-Phase 2 meeting with the FDA addressed
non-clinical and clinical topics, including discussions on the size
of the required safety database, and the main design elements of
repeat dose study and the comparative bioavailability study
required to satisfy requirements for the 505(b)(2) approval
pathway.
Based on the detailed and informative interaction with the FDA,
at this time, Eupraxia anticipates that the remaining clinical
trials to support a 505(b) application for EP-104IAR will consist
of:
- PROMENADE 1 – A Phase 3 trial in approximately 740
knee OA patients to confirm the safety and efficacy of a single
dose of EP-104IAR for six months post-dose. The Company anticipates
that a subset of patients will be followed for one year.
- PROMENADE 2 – A Phase 3 trial in approximately 300
patients to evaluate the safety and durability of response after a
second dose of EP-104IAR. Eupraxia anticipates that the trial will
be run in parallel with PROMENADE 1 and patients will be followed
for a maximum of nine months after the second injection.
- A Phase 1 study carried out in approximately 30 patients
comparing the pharmacokinetics of EP-104IAR and Flovent®
HFA.
"The FDA is aware of the challenges in developing drugs for OA
pain and has engaged with the Company in collaborative and
informative discussions on reviewing its expectations, including
key aspects of our prospective Phase 3 program's clinical
endpoints," said Dr. James
Helliwell, CEO of Eupraxia. "Based on this productive
End-of-Phase 2 meeting with the FDA, Eupraxia believes that it has
a clear understanding of how to proceed into a Phase 3 clinical
development program."
Eupraxia intends to aggressively pursue its Phase 3 program and
continue to engage with the FDA on specific aspects of the program.
The Company's recently granted Fast Track designation from the FDA
for EP-104IAR recognizes the significant unmet medical need in knee
OA.
Background on the End-of-Phase 2
Meeting With the FDA
The FDA was recently presented with clinical results from
Eupraxia's SPRINGBOARD Phase 2b trial
in 318 knee OA patients. The trial met its primary endpoint, with a
clinically meaningful and statistically significant (p=0.004)
improvement in WOMAC Pain over vehicle placebo at 12 weeks in the
Intent-to-Treat population. Notably, this pain relief extended to
17 weeks in the patients experiencing moderate levels of pain at
baseline (comprising approximately 70% of symptomatic knee OA
patients) and at all but one timepoint to 17 weeks in the Per
Protocol population.
The Company anticipates that official FDA minutes from the
End-of-Phase 2 meeting should be available within one month. A
separate End-of-Phase 2 meeting with the FDA is intended for later
in 2024 to confirm manufacturing expectations.
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. alone. This includes 14 million that
suffer from knee pain or some form of disability. 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. The Company believes 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 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 is designed to prolong the duration of 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 the
corticosteroid slowly into the knee joint providing local
therapeutic concentrations for up to six months. This has the
potential dual advantage of providing longer duration of pain
relief with fewer systemic side effects. A robust safety and
tolerability 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. EP-104IAR has also
been designed to incorporate additional advantages, such as
physician convenience, 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 products
that have the potential to address therapeutic areas with high
unmet medical need. The Company strives to provide improved patient
benefit and has developed technology designed to deliver targeted,
long-lasting activity with fewer side effects. Diffusphere™, a
proprietary, polymer-based micro-sphere technology, is designed to
facilitate targeted drug delivery, with extended duration of
effect, and offers multiple, highly tuneable PK profiles. This
investigational technology can be engineered for use with multiple
active pharmaceutical ingredients and delivery methods.
Eupraxia recently completed a Phase 2b clinical trial for its lead product candidate,
EP-104IAR, for the treatment of pain due to OA of the knee. The
trial met its primary endpoint and three of the four secondary
endpoints. Eupraxia has expanded the EP-104 platform into
gastrointestinal disease and has initiated a Phase 1b/2a program for treating eosinophilic
esophagitis (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 applicable
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", "hopes", "endeavours",
"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 3 development program for EP-104AR,
including with respect to anticipated timing of the program, dosing
of the first patient, the remaining clinical program for
registration and the details thereof; the Phase 1 study comparing
the pharmacokinetics of EP-104IAR and Flovent® HFA; the Company's
End-of-Phase 2 meeting with the FDA and the availability of
official minutes thereof; the Company's continued engagement with
the FDA, including the intention for a separate End-of-Phase 2
meeting; the ability of the Company to execute on its business
strategy; the potential of Eupraxia's product candidates, including
EP-104IAR with respect to the treatment of knee OA; the Company's
expectations regarding its product designs, including with respect
to patient benefit, duration, safety, effectiveness and
tolerability; the potential and competitive advantages of
Diffusphere™ in connection with the drug delivery process; the
advancement of opportunities stemming from Diffusphere™ and the
expansion of pipeline designs; 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 the use of the terms "EP-104IAR", "EP-104GI", and
"EP-104" in future disclosure.
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's clinical trials may fail to demonstrate adequately
the safety and efficacy of our product candidates at any stage of
clinical development; the Company may be required to suspend or
discontinue clinical trials due to side effects or other safety
risks; 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 health
pandemics on the Company's operations; the Company's restatement of
its consolidated financial statements, which may lead to additional
risks and uncertainties, including loss of investor confidence and
negative impacts on the Company's common share price; and other
risks and uncertainties described in more detail in Eupraxia's
public filings on SEDAR+ (sedarplus.ca). 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.