Full Press Release Details
Eupraxia Pharmaceuticals Announces
Positive Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Victoria, B.C. - February 25, 2025 -
Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage biotechnology
company specializing in precision local drug delivery, today announced additional positive clinical data from its ongoing RESOLVE Phase
1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").
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. The Company's
ongoing RESOLVE trial is a Phase 1b/2a, multi-center, open-label, dose-escalation study that is evaluating EP-104GI across multiple patient
cohorts by assessing key clinical measurements associated with EoE, including SDI, impact on tissue health (histology) as measured by
EoEHSS, and the measurement of peak eosinophil count ("PEC").
"In the RESOLVE trial, positive efficacy
and safety outcomes continue to be observed," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "We believe the
positive dose-response data from these first six cohorts clearly demonstrate that precise, localized delivery of EP-104GI at higher doses
is leading to further improvements in both tissue health and symptom reductions. Also, no serious adverse events nor events of oral or
gastrointestinal candidiasis, commonly seen in EOE patients being treated with steroids, have been observed in any of the first six Cohorts."
"We are highly encouraged by the fact
that EP-104GI has demonstrated strong activity despite only being administered to varying portions of the esophagus to this point in the
trial. This suggests that maximizing esophageal coverage with EP-104GI could lead to further improvements in histology and symptoms. Based
on these observations, and the safety results to date, we intend to further explore the potential treatment effect of EP-104GI at higher
dosing levels and over expanded esophageal coverage in the upcoming cohorts. The collective safety and efficacy data from the RESOLVE
study continue to demonstrate that EP-104GI has the potential to become a new standard of care for the treatment of EoE, and we look forward
to reporting the first set of nine-month data from the RESOLVE study in the second quarter."
Key Findings from the Sixth Cohort of the RESOLVE Trial
Each patient in the sixth cohort received
16 injections of 4 mg EP-104GI (total dose: 64 mg) targeting the lower three-quarters of the esophagus. The results include:
Key Findings from Dose Escalation Data
As the table below demonstrates, there
is a clear effect of dose on both patient symptoms (SDI) and tissue health (PEC and EoEHSS). These effects are comparable to, or better,
than what has been demonstrated by currently approved treatments for EoE.
| Cohort | Number of Injections | Esophageal Coverage (%) | Drug/ Injection | SDI | PEC (12 wks) * | EoEHSS (12 wks) ** | |||
| (12 wks) | (24 wks) | Peak Reduction | Remission Rate | Stage | Grade | ||||
| 3 | 8 | 8 cm (~40%) | 2.5 mg | -28% | -17% | -55% | 19% | -15% | -7% |
| 4 | 12 | 12 cm (~60%) | 2.5 mg | -45% | -55% | -67% | 29% | -39% | -37% |
| 5 | 12 | 12 cm (~60%) | 4 mg | -41% | -82% | -83% | 38% | -54% | -54% |
| 6 | 16 | 16 cm (~80%) | 4 mg | -46% | TBD | -94% | 62% | -66% | -65% |
* PEC (Peak Eosinophil Count) is reported as
peak reduction across a standard number of biopsy sites in the treatment area and remission rate is the percentage of biopsy sites (across
all sites) with complete remission (PEC 6)
** EoEHSS (Eosinophilic Esophagitis
Histology Scoring System) is a composite score of various histological inflammatory measures, split into separate metrics of "stage"
(extent) and "grade" (severity).
Webinar to discuss results
will host a Webinar this Wednesday, February 26th at 11:00am PT. Please click on the link below to register for the Webinar:
About the RESOLVE Trial
The RESOLVE trial is a Phase 1b/2a, multicenter,
open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically
confirmed active EoE. The treatment is administered as a single dose via four to 20 esophageal wall injections, with dose escalations
modifying either the dose per site or the number of sites. Patients in Cohorts 1-4 were evaluated for up to 24 weeks, while patients in
Cohorts 5 and beyond are assessed for up to 52 weeks. Eupraxia plans to disclose additional data periodically.
With Cohort 7 fully enrolled, Eupraxia anticipates
releasing 12-week data in late Q2 2025.
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", "encouraged", "ongoing", "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 Company's plans for future cohorts; the
Company's expectations regarding the release of Cohort 7 data; 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