- No serious or treatment related adverse events in either the
first or second cohort
- Second cohort demonstrated an average 60% reduction in
Dysphasia Likert score and an average 80% reduction in Odynophagia
Likert score
- First cohort maintaining signs of efficacy to six months
- Third cohort now fully dosed at five times the first cohort
dose and two-and-a-half times the second cohort dose
- Results from third cohort are expected in the second quarter of
2024
VICTORIA, BC, Feb. 5, 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 updated
positive clinical data from its Phase 1b/2a RESOLVE trial, which is evaluating safety
and efficacy of EP-104GI as a treatment for eosinophilic
esophagitis ("EoE").
EoE is a life altering, chronic, immune-mediated condition of
the esophagus that causes inflammation, structural damage and
dysfunction when left untreated. Patients with EoE experience
difficulty and pain in swallowing; the extent of which can
dramatically affect their quality of life. Current treatment
options often provide poor or temporary control over the condition
and can be accompanied with unpleasant side effects, such as oral
fungal infections.
"Our goal for EP-104GI is to develop a product that provides
potent and targeted immunotherapy to the esophagus with minimal
systemic exposure and side effects," said Dr. James Helliwell, CEO of Eupraxia. "The updated
data announced today from our RESOLVE trial in EoE demonstrate good
tolerability and early efficacy signals from patients treated with
EP-104GI, as well as evidence of a positive dose response. We
believe that EP-104GI has the potential to meet our target profile
and become an important treatment for EoE."
Positive Clinical Data from the RESOLVE Trial
The results announced today from the second cohort of the
RESOLVE trial, using Eupraxia's Diffusphere™ technology for EoE,
are derived from a low dose of eight 1 mg injections of EP-104GI
administered to a portion of each patient's lower esophagus.
- There were no serious adverse events or treatment-related
adverse events in either cohort.
- All three of the patients in the second dose cohort showed
reductions in their patient-reported outcomes with an average 60%
reduction in their Dysphasia Likert score (difficulty swallowing)
and an 80% reduction in their Odynophagia Likert score (pain on
swallowing) at three months.
- Patients demonstrated an average 40% reduction in eosinophil
counts at three months in the second cohort.
- Plasma levels of fluticasone were very low (˂ 10pg/mL),
supporting the potential to increase the dose in future cohorts. In
previous Eupraxia studies, similar plasma levels of fluticasone had
no effect on serum cortisol or blood glucose.
- Patients receiving the very low dose (four 1 mg injections)
from the first cohort who reached the six-month mark still reported
some beneficial effects from the treatment.
- The data supports the hypothesis that as the dose increases,
the response improves. The first six patients showed meaningful
improvement in self-reported symptoms and pathological findings of
the disease assessed by esophageal biopsies. These findings are
viewed optimistically in light of the low doses used in the first
two cohorts.
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 duration of efficacy endpoints. Durability of
response is evidenced by the continued meaningful improvement in
symptoms at six months in the first cohort with a low dose,
and Eupraxia intends to follow all future cohorts
to six months.
The third cohort of the RESOLVE trial has been fully recruited
and the dosing is five times that of the first cohort (which was
four 1 mg injections), with eight 2.5 mg injections offering a
higher local dose and a broader spread of drug in the esophagus.
The trial's third cohort has now been fully dosed and further
results are expected in the second quarter of 2024.
The Company anticipates also releasing additional interim data
as the study progresses.
About Eosinophilic Esophagitis (EOE)
EoE is a life altering, chronic, immune-mediated condition in
which white blood cells migrate into the esophagus, causing
inflammation, structural damage and dysfunction when left
untreated. Patients with EoE experience difficulty and sometimes
severe pain in swallowing; the extent of which can dramatically
affect their quality of life. Current treatment options often
provide poor or temporary control over the condition and can be
accompanied by unpleasant side effects, such as oral fungal
infections. Impacts from both symptoms and interventions frequently
lead to mental health issues, compounding the disease burden of EoE
for both the health care system and the individual.
About the RESOLVE Trial
RESOLVE is a Phase 1b/2a
open-label dose-ascending trial with the primary objectives set to
evaluate the safety and pharmacokinetic profile of EP-104GI when
administered to the esophagus. The trial also includes a secondary
objective to evaluate the efficacy of EP-104GI on EoE disease
activity as measured by symptoms, endoscopy, and histology. The
trial consists of three patients per cohort and a maximum of five
cohorts for a total target enrollment of up to 24 patients enrolled
from centres in Canada,
the Netherlands and Australia.
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 with the Phase 1b/2a RESOLVE trial 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 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", "estimates", "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
clinical trials, including with respect to the potential for higher
doses; the ability of the Company to execute on its business
strategy; the potential of Eupraxia's product candidates, including
EP-104GI with respect to the treatment of EoE; 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 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; 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 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).
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.