- EP-104IAR and EP-104GI continuing to advance clinically &
remain on track
- Corporate initiatives ongoing to position EP-104IAR and
EP-104GI for successful outcomes
- Company provides milestones for 2024
VICTORIA, BC, Dec. 11,
2023 /CNW/ - Eupraxia Pharmaceuticals Inc.
("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage
biotechnology company, today announced updates for its two clinical
programs, EP-104IAR, its lead drug candidate in development for the
treatment of knee osteoarthritis ("OA"), and EP-104GI, a
high-potential product candidate in development for the treatment
of eosinophilic esophagitis ("EoE").
In addition, the Company provided a progress update on a number
of key corporate initiatives.
"Eupraxia continues to make significant progress in the clinical
development of EP-104IAR and EP-104GI, building on the strong data
reported to date, as we work to finalize the path forward for
later-stage clinical testing," said Dr. James Helliwell, CEO of Eupraxia. "Concurrently,
we are working through a number of key corporate initiatives,
reflecting our growing scale, compelling delivery technology and
evolving clinical programs, with the ultimate goal of positioning
EP-104IAR and EP-104GI for successful outcomes."
EP-104IAR Update
The Company has submitted the required dossier to support an
End-of-Phase-2 meeting with the U.S. Food and Drug Administration
("FDA"), which is currently scheduled for late January 2024.
Management believes its recently completed Phase 2 trial, now
named the "SPRINGBOARD" trial, was adequate and well controlled and
has the potential to become one of the pivotal studies necessary to
support approval. At the upcoming FDA meeting, the Company
anticipates receiving confirmation of acceptance of its Phase 2
study, as well as the planned path forward for its Phase 3 study.
The Company also anticipates further guidance on the
potential for repeat and bi-lateral dosing. Management believes
these additional features are important differentiators for the
product commercially.
An MRI sub-study continues in selected patients from the Phase 2
trial for EP-104IAR, with additional data on inflammation and
cartilage health anticipated in the first quarter of 2024.
Management expects this data will potentially provide further
evidence of the safety profile of EP-104IAR for patients. This
sub-study is small (n=13), and the primary objective is to better
inform Eupraxia on the potential use of MRI technology as
supportive evidence in the path forward.
EP-104GI Update
The Company is looking forward to releasing data from the first
cohort of its ongoing Phase 1b/2a
program, now named the "RESOLVE" trial, to treat EoE.
The Company anticipates releasing data by cohort and intends to
present safety and efficacy data up to three months from the first
cohort in the near term. The Company has previously announced that
based on its first external safety review meeting of the RESOLVE
trial, the original timeline of the trial was extended to six
months to fully characterize the pharmacokinetics (PK) and duration
of efficacy that has been demonstrated.
The trial's second cohort has now been fully dosed and further
results of the second cohort up to three months are expected in the
first half of 2024.
Progress Update on Key Corporate
Initiatives
Effective at the end of the 2023 fiscal year, the Company will
be transitioning its accounting and financial reporting to U.S.
dollars and U.S. GAAP. Management believes this transition will
support improved access to capital moving forward and additional
flexibility in terms of public share registration.
Eupraxia has now also completed the previously announced
transition to a new auditor, KPMG, which is expected to further
support its corporate plans.
The Company continues to explore partnering opportunities for
all development candidates outside the U.S.
Platform Technology
Developments
Based on the growing volume of pre-clinical and clinical data
reported by the Company, management believes clear proof-of-concept
has been established for its underlying delivery technology.
To fully differentiate its technology, and establish a clear
commercial position in the marketplace, Eupraxia has formally
branded the technology as Diffusphere™.
Diffusphere™, a proprietary, polymer-based micro-sphere
technology, facilitates targeted drug delivery, with extended
duration of effect, and offers multiple, highly tunable PK
profiles. Diffusphere™ can be used with multiple active
pharmaceutical ingredients and delivery methods. The Company
intends to fully leverage Diffusphere™ with additional pipeline
candidates and explore potential out-licensing opportunities with
third-party drug developers.
Summary of 2024
Milestones
Looking forward, the Company anticipates it will achieve a
number of significant milestones in fiscal 2024. These include:
- End-of-Phase 2 meeting results with the FDA on EP-104IAR
- Interim data from the Company's ongoing imaging sub-study for
EP-104IAR
- Additional interim data (by cohort) for EP-104GI from the
RESOLVE trial
- Dosing the first patient in a Phase 3 trial for EP-104IAR
- Participating in a Pre-Investigational New Drug meeting with
the FDA on EP-104GI
- Nominating additional pipeline candidates
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 that delivers targeted,
long-lasting activity with fewer side effects.
Eupraxia's lead product candidate, EP-104IAR, recently completed
a Phase 2b clinical trial for the
treatment of pain due to osteoarthritis of the knee. EP-104IAR met
its primary endpoint and three of the four secondary endpoints. The
EP-104 platform has expanded into gastrointestinal disease and has
initiated a Phase 1b/2a 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" 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 completion of the
Company's Phase 2 trial and the path forward for its Phase 3 trial;
the ability of the Company to execute on its business strategy,
including the anticipated achievement of certain milestones in
fiscal 2024; statements regarding the End-of-Phase 2 meeting with
the FDA; the potential of Eupraxia's product candidates, including
the clinical advancement and projected outcomes of EP-104IAR and
EP-104GI; the Company's expectations regarding its product designs,
including with respect to patient benefit, duration, safety,
effectiveness and tolerability; the results gathered from studies
of Eupraxia's product candidates and the timing of release thereof,
including with respect to the Company's MRI sub-study and RESOLVE
trial; 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; statements
regarding changes to the Company's accounting and financial
reporting; the expected support of KPMG as the Company's new
auditor; 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 its 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 the COVID-19
pandemic 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.