Eupraxia Pharmaceuticals Announces Initiation of Second Cohort in Phase 1b/2a Clinical Trial in Eosinophilic Esophagitis
- 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.
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.
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.
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", "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 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.
For investor and media inquiries, please contact: Danielle Egan, Eupraxia Pharmaceuticals Inc., 778.401.3302, [email protected] or Adam Peeler, on behalf of: Eupraxia Pharmaceuticals Inc., 416.427.1235, [email protected]
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