- DiffuSphere™ is designed to enable precise drug delivery at
therapeutic dose levels directly into target tissues, enhancing
efficacy while minimizing systemic drug levels to optimize
safety
- In clinical trials, a single administration
of DiffuSphere™ successfully delivered fluticasone propionate
for at least six months in patients with eosinophilic esophagitis
or osteoarthritis
- DiffuSphere™ has shown its versatility with various drug
classes, supporting the possibility to treat multiple types of
pain, infectious diseases, eye diseases and cancers
VICTORIA, BC, Nov. 20,
2024 /CNW/ - Eupraxia Pharmaceuticals Inc.
("Eupraxia" or the "Company") (NASDAQ: EPRX) (TSX: EPRX), a
clinical-stage biotechnology company, today unveiled new
pharmacokinetic ("PK") data from its Phase 2a Eosinophilic
Esophagitis ("EoE") program. Management believes these data
underscore the unique capabilities of Eupraxia's proprietary
DiffuSphere™ platform technology, which aims to provide precise,
localized, safe, and effective long-lasting drug delivery.
Most conventional drugs release in a pattern characterized by
steep peaks and rapid declines in drug concentration, where peaks
often lead to negative side effects, and troughs result in reduced
efficacy. In contrast, DiffuSphere™ is a unique microsphere
that is designed to enable precise drug release into target tissues
with a flat, stable, and long-lasting profile, minimizing potential
adverse events associated with high-dose systemic
delivery.
What sets DiffuSphere™ apart is its composition: a pure
drug crystal encased in a microns-thick polymer shell. Eupraxia's
proprietary technology uses this polymer to precisely control a
drug's release, ensuring high drug concentrations in the target
tissues while minimizing exposure to the rest of the body. This
innovative approach has been observed in Eupraxia's clinical
programs, demonstrating precision, tolerability, and extended
duration of delivering fluticasone propionate ("FP") directly to
the intended tissues for EoE and knee osteoarthritis ("OA")
patients.
"Our DiffuSphere™ platform is designed to enable us to deliver
the right drug to the right place at the right time with a precise
PK profile, aiming to ensure patients receive safe, effective, and
durable treatment," said Eupraxia's CEO, Dr. James Helliwell. "We are excited about the
broad-based potential of DiffuSphere™. The clinical data from EoE
and OA, combined with our extensive non-clinical data showing
precise delivery of numerous drugs in a broad array of target
tissues, reinforces our optimism."
RESOLVE Trial Demonstrates Compelling Pharmacokinetics in the
Esophagus
DiffuSphere™, when injected into the esophageal wall
(submucosa), shows a treatment duration exceeding six months from a
single injection, with predictable dose control. In Cohort 1 (4 mg
FP), a steady level of 1.5 pg/ml was maintained for at least six
months. In Cohort 5 (48 mg FP), 10pg/ml was observed at three
months. With this steady, localized, and long-lasting delivery, key
EoE disease measures, including patient symptoms, esophageal tissue
health, and eosinophil counts, improved. This impact of the
DiffuSphere™ technology was clearly demonstrated in a non-clinical
study in pigs comparing local and systemic levels of FP after
intraesophageal injection of EP-104GI versus oral gavage. Presented
at the American College of Gastroenterology meeting (poster), the
study revealed that esophageal tissue levels of fluticasone were
more than 1000 times higher in the EP-104GI group compared to the
oral gavage group, even at distances of several centimeters from
the injection sites. Moreover, despite significantly higher local
concentrations, systemic levels of fluticasone in the plasma were
lower in the EP-104IAR group than in the oral gavage group. This
underscores the targeted and precise delivery capabilities of the
DiffuSphere™ technology.
DiffuSphere™ in the Joint
DiffuSphere™ is the technology behind Eupraxia's EP-104IAR for
treating OA. In Eupraxia's Phase 2b
clinical study, EP-104IAR was well tolerated and showed
significantly durable efficacy over placebo. The trial results were
recently published in The Lancet, reinforcing the
preclinical work previously published in Cartilage. The
Phase 2b data showed that EP-104IAR
effectively controlled patients' pain for up to 22 weeks (as
measured by OARSI Strict Responders) and was well-tolerated. This
includes no disruption to blood glucose metabolism (a key factor
for diabetics, who comprise almost 40% of the OA population) or
adrenal function, which have been reported with other steroid
formulations used in this indication.
DiffuSphere™ in Other Applications
Eupraxia has successfully applied DiffuSphere™ across multiple
anatomic locations and drug classes. In preclinical studies,
DiffuSphere™ has demonstrated its precise, steady, and tunable
delivery traits in intraarticular, intraesophageal, intravitreal,
epidural, peritoneal, and subcutaneous applications. Additionally,
Eupraxia has demonstrated DiffuSphere's™ capability with local
anesthetics such as ropivacaine and various anti-infective
agents.
The new data in EOE patients further supports DiffuSphere's™
ability to deliver drugs with local precision: stable drug delivery
without peaks and troughs, and a customizable duration to fit the
clinical indication. This reinforces Eupraxia's confidence in the
platform's broad potential.
About Eosinophilic Esophagitis (EOE) and the RESOLVE
Trial
EoE is an inflammatory-mediated disease in which white blood
cells migrate into and become trapped in the esophagus, creating
pain and difficulty with swallowing food. According to market
research from Clearview Healthcare Partners, EoE affects more than
450,000 people in the United
States and has been identified by the American
Gastroenterological Association as rapidly increasing in both
incidence and prevalence. Impacts from both symptoms and
interventions frequently lead to mental health issues, compounding
the disease burden of EoE for both the healthcare system and the
individual.
RESOLVE is a Phase 1b/2a,
multicenter, open-label, dose-escalation study to evaluate the
safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in
adults with histologically confirmed, active EoE. EP-104GI is
administered as a single dose via four to 20 injections into the
esophageal wall. Dose escalations increase the dose per site and/or
number of sites. Participants in the first through the fourth
cohorts will be assessed for up to 24 weeks, and cohorts five and
above will be assessed for up to 52 weeks.
About Osteoarthritis (OA)
Eupraxia's OA 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 adverse events. 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 adverse events. 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
developing 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 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. Eupraxia also recently completed a
Phase 2b clinical trial (SPRINGBOARD)
of EP-104IAR for the treatment of pain due to knee osteoarthritis.
The trial met its primary endpoint and three of the four secondary
endpoints. 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", "aims", "suggests", "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 product candidates,
including their expected benefits to patients with respect to
safety, tolerability, efficacy and duration; additional clinical
data from the RESOLVE trial of EP-104GI in EoE, including the
Company's intention to periodically disclose such data and timing
thereof; the Company's expectations regarding dose-escalating
cohorts; the results gathered from studies and trials of Eupraxia's
product candidates; 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.