Full Press Release Details
Eupraxia Pharmaceuticals Announces
Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Victoria, B.C. - November 12,
2024 - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage
biotechnology company developing precision drug delivery for indications with significant unmet need, today announced additional positive
clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic
esophagitis ("EoE").
New Clinical Data from the Fifth Cohort of the RESOLVE
The results announced today from the
fifth cohort of the RESOLVE trial, for treatment of EoE, are derived from 12, 4 mg injections of EP-104GI (total dose of 48 mg) administered
to the lower two-thirds of each patient's esophagus. The data show:
Plasma fluticasone levels continue
to be predictable and well-below published levels of daily fluticasone asthma treatments. "As the RESOLVE trial advances, we are
observing increasingly positive data on efficacy and safety outcomes, including no adverse events such as candidiasis, adrenal suppression
or glucose derangement," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "Notably, higher dosing levels are
yielding improved patient responses, such as histological remission, enhanced patient-reported symptom scores, and favourable histology
results, all without reaching a maximum tolerated dose thus far."
The RESOLVE trial is a Phase 1b/2a,
multicentre, 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 a patient's esophageal
wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts have been
assessed for up to 24 weeks. Patients in cohorts five and above will be assessed for 52 weeks.
The Company intends to continue to
periodically disclose additional data from the trial.
New Clinical Data from the Fourth
Cohort in the RESOLVE Trial
The results announced today from the
fourth cohort of the RESOLVE trial in EoE, are derived from 12, 2.5 mg injections of EP-104GI (total dose of 30 mg) administered to a
portion of each patient's lower esophagus. The data show:
SDI1 scores continued to improve out to 24
weeks (average four-point reduction), showing the largest reduction in scores for any cohort to date at this time point.
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.
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 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", "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.
For investor and media inquiries, please contact:
Danielle Egan, Eupraxia Pharmaceuticals Inc.
Adam Peeler, on behalf of:
Eupraxia Pharmaceuticals Inc.