- Preliminary data from the first cohort demonstrates that
EP-104GI was well tolerated with no drug-related adverse events
reported
VICTORIA, BC, Oct. 11,
2023 /CNW/ - Eupraxia Pharmaceuticals Inc.
("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage
biotechnology company with an innovative drug delivery technology,
today announced the initiation of the second cohort for its Phase
1b/2a clinical trial in eosinophilic
esophagitis ("EoE").
The Company's Safety Review Committee approved dose escalation
in the second cohort based on data available from the trial's first
cohort. In addition, Eupraxia has submitted to regulators an
amendment to the protocol for additional assessments of efficacy
and pharmacokinetics ("PK") at six months in all cohorts. The full
dataset from the first cohort will be released when completed.
"The initiation of a second cohort for our Phase 1b/2a clinical trial in EoE demonstrates that we
continue to make progress 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 remain optimistic that
EP-104GI has the potential to become an important treatment for
EoE."
The Phase 1b/2a trial is an open
label trial with the primary objectives set to evaluate the safety
and PK 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 is a dose-ascending trial consisting of three patients
per cohort and a maximum of five cohorts for a total target
enrollment of up to 15 patients enrolled from centres in
Canada, the Netherlands and Australia.
Preliminary Data From the First
Cohort
In this first in-human cohort, patients were administered a
total dose of four injections of 1 milligram (mg) of EP-104GI for a
total of 4 mg. The product was well tolerated with no drug-related
adverse events reported.
PK analysis shows that systemic exposure of fluticasone is
minimal, and at levels well below those seen with approved
fluticasone products for inhalation. As this is primarily a safety
study, the Company had no expectation of observing efficacy at this
low dose. However, Eupraxia believes that the preliminary efficacy
results on symptom improvement, including the duration of this
improvement, are encouraging.
The tolerability and PK profile of EP-104GI support proceeding
to the next cohort which will be administering eight injections of
1 mg of EP-104GI for a total dose of 8 mg.
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
completed the first cohort in 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",
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(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
1b/2a trial, including initiation of
the second cohort, assessment objectives and expected timing with
respect to the reporting of results and trial completion; the
anticipated dosage used in the phase 1b/2a trial; the potential of Eupraxia's product
candidates, including EP-104GI 's potential to treat EoE; the
Company's expectations regarding its product designs, including
with respect to targeted shelf life, storage, ease of integration,
duration, activity, tolerability, effectiveness and safety; the
results gathered from studies of Eupraxia's product candidates; the
potential for the Company's technology to impact the drug delivery
process; the competitive advantages of the Company's technology;
the benefits to patients from the Company's drug platforms; and the
translation of the Company's technologies and expansion of its
offerings into clinical applications. 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 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; and other risks and
uncertainties described in more detail in Eupraxia's public filings
on SEDAR+ (www.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.