Eupraxia Pharmaceuticals Announces Last Patient Last Visit in Phase 2 Osteoarthritis Clinical Trial of EP-104IAR
VICTORIA, BC, May 25, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has reached the last patient last visit in its Phase 2 clinical trial of EP-104IAR for osteoarthritis ("OA").
Dr. James Helliwell, CEO of Eupraxia, commented, "Our team has worked effectively to rapidly advance this study while navigating the unique challenges of a global pandemic. This is an important milestone toward the completion of the study, and we remain on track for top-line data readout in the second quarter of this year."
Management believes that the top-line data readout will be well powered and has the potential to demonstrate a meaningful reduction in OA knee pain with a corresponding improvement in patient function and an extended duration of effect. Based on previously released blinded safety data the Company also believes EP-104IAR has the potential for a best-in-class safety profile, potentially allowing for bilateral and chronic dosing regimens.
The Phase 2 trial readout should also offer important validation of the underlying delivery technology, with highly tunable kinetics and extended duration of effect. The Company intends to further exploit this technology in additional drug candidates.
The Phase 2 trial is a randomized, double blind, vehicle-controlled study of 300 OA patients with moderate to severe pain scores as evaluated by Kellgren-Lawrence grade (2-3). The primary endpoint in the study is the difference in change from baseline between EP-104IAR and the vehicle control in (Western Ontario and McMaster Universities ("WOMAC") pain score at 12 weeks.
Secondary endpoints include the difference in change from baseline in WOMAC pain scores continuing to 24 weeks as well as composite pain/function scores. In addition, the study supports a significant safety evaluation of the drug including evaluation of systemic and local toxicity as well as changes in cortisol levels.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to osteoarthritis of the knee. The EP-104 platform has expanded into gastrointestinal disease with the launch of a Phase 1b/2a program to treat eosinophilic esophagitis. 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" 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; the timing and potential of top-line data readout; the ability of the Company to execute on its business strategy; the potential of Eupraxia's product candidates; the Company's expectations regarding its product designs, including with respect to patient benefit, duration, safety and effectiveness; 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'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; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR (www.sedar.com). 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.
SOURCE Eupraxia Pharmaceuticals Inc.
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