- Initial low dose presents early efficacy signals
- Second cohort now fully dosed at twice the initial dose
- Further results to be disclosed in Q1 2024
VICTORIA, BC, Dec. 12,
2023 /CNW/ - Eupraxia Pharmaceuticals Inc.
("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage
biotechnology company, today announced 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").
"The data announced today from our RESOLVE trial in EoE
demonstrate early efficacy signals from patients treated with
EP-104GI," said Dr. James Helliwell,
CEO of Eupraxia. "EoE is a chronic, immune-mediated condition of
the esophagus that causes inflammation, structural damage and
dysfunction when left untreated. It adversely affects patients and
burdens the healthcare system, as current treatment options often
provide poor or temporary control over the condition. We believe
that EP-104GI has the potential to become an important treatment
for EoE."
Positive Clinical Data from the
RESOLVE Trial
The results announced today from the first cohort of the RESOLVE
trial, treating EOE using Eupraxia's Diffusphere™ technology, are
derived from a low initial dose of four 1 mg injections of EP-104GI
injected in a small portion of each patient's lower esophagus.
The data indicate efficacy signals at this initial, low dose.
The cohort's first patient had very severe disease in the distal
esophagus (where the injections were given) and on entry into the
trial had severe difficulty swallowing (dysphagia), and significant
pain on swallowing (odynophagia) with frequent bouts of vomiting.
Within two weeks, these symptoms had been reduced significantly.
This patient has maintained this high degree of response until week
12 of the trial where they remain asymptomatic.
The other two patients in this cohort had diffuse disease
throughout the esophagus (far away from where the injection
occurred) and therefore Eupraxia did not expect any clinical
response. Both patients showed meaningful improvement in their
dysphagia and odynophagia scores after treatment in addition to
improvements in their Strauman Dysphagia Index scores. Histology
results in all patients are inconclusive in this first cohort.
These results from the first cohort of a very low dose of
EP-104GI in a small area of the esophagus has resulted in
meaningful symptom improvement in all patients to at least 12
weeks. This response is believed to be indicative of the potential
for higher doses to spread more diffusely through the esophagus and
provide a more pronounced and prolonged response in this
difficult-to-treat population.
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. As is evident by the
continued meaningful improvement at three months in this first
cohort with a low dose, Eupraxia is looking forward to
following patients in this and subsequent cohorts to six
months.
The second cohort of the RESOLVE trial has been fully recruited
and the dosing doubled from the initial cohort, with eight 1 mg
injections offering broader coverage of the esophagus. The trial's
second cohort has now been fully dosed and further results are
expected in the first quarter of 2024.
The Company anticipates also releasing additional interim data
as the study progresses.
About the RESOLVE Trial
RESOLVE is a Phase 1b/2a
open-label 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. RESOLVE is an
unblinded, dose-ascending trial consisting 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 that delivers targeted,
long-lasting activity with fewer side effects. Diffusphere™, a
proprietary, polymer-based micro-sphere technology, facilitates
targeted drug delivery, with extended duration of effect, and
offers multiple, highly tuneable PK profiles. The technology can be
used with multiple active pharmaceutical ingredients and delivery
methods.
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 Company's Phase 2 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 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.