- Publication of Eupraxia's Phase 2b data in Lancet Rheumatology, a
distinguished and respected journal, raises the profile of
EP-104IAR.
- As outlined in Lancet Rheumatology, Eupraxia's
EP-104IAR imparts clinically significant and durable pain relief,
while also having minimal changes in glucose and cortisol, along
with stable fluticasone proportionate concentrations in
plasma.
- The U.S. Centers for Disease Control and Prevention estimates
that knee osteoarthritis affects more than 30 million people in the
U.S. alone.
VICTORIA, BC, Oct. 15,
2024 /PRNewswire/ - Eupraxia Pharmaceuticals
Inc. ("Eupraxia" or the "Company") (NASDAQ: EPRX) (TSX: EPRX), a
clinical-stage biotechnology company leveraging its proprietary
DiffuSphere™ technology to optimize drug delivery for applications
with significant unmet need, today announced that Lancet
Rheumatology, a leading independent, peer-reviewed journal
committed to sharing progressive content relevant to rheumatology
specialists worldwide, recently published Eupraxia's Phase 2 data
from its SPRINGBOARD trial evaluating EP-104IAR for the treatment
of knee osteoarthritis.
The publication is titled, "Efficacy and safety of a novel
extended-release fluticasone propionate intra-articular injection
(EP-104IAR) in knee osteoarthritis: a randomized,
vehicle-controlled, double-blind, multi-centre, 24- week, Phase 2
trial (SPRINGBOARD)". A link to the paper can be found here.
"The publication of our Phase 2b
data in a distinguished and respected journal such as Lancet
Rheumatology raises the profile of EP-104IAR and further
underscores the potential of this product candidate to become a
best-in-class therapy for the treatment of knee osteoarthritis,"
said Dr. James Helliwell, CEO of
Eupraxia. "As outlined in the publication, EP-104IAR imparts
clinically significant and durable pain relief, while also having
minimal changes in glucose and cortisol, along with stable
fluticasone proportionate concentrations in plasma. We continue to
evaluate multiple program advancement strategies for this exciting
and highly differentiated Phase 3-ready clinical asset that we
believe holds the potential to advance the standard of care for
individuals suffering from knee osteoarthritis."
"By utilizing an advanced formulation technology, the improved
pharmacokinetic and pharmacodynamic profile of EP-104IAR appears to
offer strong and sustainable pain relief and shows the potential to
significantly improve upon the safety profile for this drug class,"
said Philip Conaghan, Professor of
Musculoskeletal Medicine, University of Leeds, and an author of the
publication. "Based on the data from this Phase 2 study, I look
forward to seeing this product candidate continue to advance into
late-stage, pivotal testing."
The SPRINGBOARD trial is a multi-centre, randomized,
double-blind, vehicle controlled, parallel-group Phase 2b clinical trial that evaluated EP-104IAR for
the treatment of knee osteoarthritis. Participants (N=318) were
evaluated following a single IA dose of 25 mg EP-104IAR or vehicle
placebo. The objectives of the study were to evaluate the efficacy,
safety and pharmacokinetic profile of EP-104IAR. The 24-week
duration of the trial was anticipated to cover the period over
which fluticasone propionate is released via diffusion from the
EP-104IAR particles.
In June 2023, the Company
announced positive results from the Phase 2b clinical trial of EP-104IAR for pain
associated with knee osteoarthritis. EP-104IAR met its primary
endpoint with a clinically significant and statistically
significant (p=0.004) improvement over vehicle-placebo in WOMAC
Pain at 12 weeks. EP-104IAR also showed statistically significant
improvement over placebo at 12 weeks in three of four secondary
endpoints: WOMAC Function (p=0.014), OMERACT-OARSI strict
responders (p=0.011) and Area Under the Curve (AUC) for WOMAC Pain
(p<0.001). Importantly, statistical significance with
OMERACT-OARSI strict pain responders to 15 weeks and Area Under the
Curve for WOMAC Pain to 24 weeks was also seen in the Phase
2b study, highlighting a strong and
durable response.
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. DiffuSphere™, a proprietary, polymer-based
micro-sphere technology, is designed to facilitate targeted drug
delivery of both existing and novel drugs. The technology is
designed to support extended duration of effect and delivery of
drugs in a hyper-localized fashion, targeting only the tissues that
physicians are wanting to treat. We believe the potential for fewer
adverse events may be achieved through the precision targeting and
the stable and flat delivery of the active ingredient when using
the DiffuSphere™ technology, versus the peaks and troughs seen with
more traditional drug delivery methods. The precision of Eupraxia's
DiffuSphere™ technology platform has the potential to augment and
transform existing FDA-approved drugs to improve their safety,
tolerability, efficacy and duration of effect. The potential uses
in therapeutic areas may go beyond pain and inflammatory
gastrointestinal disease, where Eupraxia currently is developing
advanced treatments, to also be applicable in oncology, infectious
disease and other critical disease areas.
Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment
of eosinophilic esophagitis ("EoE"). EP-104GI is administered as an
injection into the esophageal wall, providing local delivery of
drug. This is a unique treatment approach for EoE. In addition,
Eupraxia is developing a pipeline of later and earlier-stage
long-acting formulations. Potential pipeline indications include
candidates for 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", "suggests", "scheduled", "intends",
"contemplates", "anticipates", "appears to", "looks forward to",
"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 product candidates, including expected
benefits to patients; the results gathered from studies and trials
of Eupraxia's product candidates; the potential for EP-104IAR to
become a best-in-class therapy, advance the standard of care for
individuals suffering from knee osteoarthritis, and improve the
safety profile for this drug class; the potential for EP-104IAR to
advance into late-stage, pivotal testing; future releases of data;
the potential for the Company's technology to impact the drug
delivery process; potential market opportunity for the Company's
products; and potential pipeline indications. 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: risks and
uncertainties related 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 health pandemics or epidemics 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) and EDGAR (sec.gov). 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.
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SOURCE Eupraxia Pharmaceuticals Inc.
