EPRX Eupraxia Pharmaceuticals Inc

• Decision to proceed with Phase 3 follows completion of End-of-Phase 2 meeting with the U.S. FDA

VICTORIA, BC, Feb. 1, 2024 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize drug delivery for applications with significant unmet need, today announced the Company has initiated its Phase 3 development program for EP-104IAR, the Company's lead drug candidate for the treatment of osteoarthritis ("OA") of the knee, following completion of its End-of-Phase 2 meeting with the U.S. Food & Drug Administration ("the FDA").

Based on this interaction, the Company anticipates it is on track to dose the first patient in its Phase 3 program in the third quarter of 2024.

The recent End-of-Phase 2 meeting with the FDA addressed non-clinical and clinical topics, including discussions on the size of the required safety database, and the main design elements of repeat dose study and the comparative bioavailability study required to satisfy requirements for the 505(b)(2) approval pathway.

Based on the detailed and informative interaction with the FDA, at this time, Eupraxia anticipates that the remaining clinical trials to support a 505(b) application for EP-104IAR will consist of:

• PROMENADE 1 – A Phase 3 trial in approximately 740 knee OA patients to confirm the safety and efficacy of a single dose of EP-104IAR for six months post-dose. The Company anticipates that a subset of patients will be followed for one year.
• PROMENADE 2 – A Phase 3 trial in approximately 300 patients to evaluate the safety and durability of response after a second dose of EP-104IAR. Eupraxia anticipates that the trial will be run in parallel with PROMENADE 1 and patients will be followed for a maximum of nine months after the second injection.
• A Phase 1 study carried out in approximately 30 patients comparing the pharmacokinetics of EP-104IAR and Flovent® HFA.

"The FDA is aware of the challenges in developing drugs for OA pain and has engaged with the Company in collaborative and informative discussions on reviewing its expectations, including key aspects of our prospective Phase 3 program's clinical endpoints," said Dr. James Helliwell, CEO of Eupraxia. "Based on this productive End-of-Phase 2 meeting with the FDA, Eupraxia believes that it has a clear understanding of how to proceed into a Phase 3 clinical development program."

Eupraxia intends to aggressively pursue its Phase 3 program and continue to engage with the FDA on specific aspects of the program. The Company's recently granted Fast Track designation from the FDA for EP-104IAR recognizes the significant unmet medical need in knee OA.

The FDA was recently presented with clinical results from Eupraxia's SPRINGBOARD Phase 2b trial in 318 knee OA patients. The trial met its primary endpoint, with a clinically meaningful and statistically significant (p=0.004) improvement in WOMAC Pain over vehicle placebo at 12 weeks in the Intent-to-Treat population. Notably, this pain relief extended to 17 weeks in the patients experiencing moderate levels of pain at baseline (comprising approximately 70% of symptomatic knee OA patients) and at all but one timepoint to 17 weeks in the Per Protocol population.

The Company anticipates that official FDA minutes from the End-of-Phase 2 meeting should be available within one month. A separate End-of-Phase 2 meeting with the FDA is intended for later in 2024 to confirm manufacturing expectations.

Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in knee OA. The U.S. Centers for Disease Control and Prevention estimates knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer from knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can significantly affect quality of life.

With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. The Company believes current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for treating knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects.

EP-104IAR is designed to prolong the duration of pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.

Injected into the knee, EP-104IAR is designed to diffuse the corticosteroid slowly into the knee joint providing local therapeutic concentrations for up to six months. This has the potential dual advantage of providing longer duration of pain relief with fewer systemic side effects. A robust safety and tolerability profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints. EP-104IAR has also been designed to incorporate additional advantages, such as physician convenience, targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.

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 designed to deliver targeted, long-lasting activity with fewer side effects. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery, with extended duration of effect, and offers multiple, highly tuneable PK profiles. This investigational technology can be engineered for use with multiple active pharmaceutical ingredients and delivery methods.

Eupraxia recently completed a Phase 2b clinical trial for its lead product candidate, EP-104IAR, for the treatment of pain due to OA of the knee. The trial met its primary endpoint and three of the four secondary endpoints. Eupraxia has expanded the EP-104 platform into gastrointestinal disease and has initiated a Phase 1b/2a program for treating eosinophilic esophagitis (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 applicable 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", "hopes", "endeavours", "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 3 development program for EP-104AR, including with respect to anticipated timing of the program, dosing of the first patient, the remaining clinical program for registration and the details thereof; the Phase 1 study comparing the pharmacokinetics of EP-104IAR and Flovent® HFA; the Company's End-of-Phase 2 meeting with the FDA and the availability of official minutes thereof; the Company's continued engagement with the FDA, including the intention for a separate End-of-Phase 2 meeting; the ability of the Company to execute on its business strategy; the potential of Eupraxia's product candidates, including EP-104IAR with respect to the treatment of knee OA; the Company's expectations regarding its product designs, including with respect to patient benefit, duration, safety, effectiveness and tolerability; the potential and competitive advantages of Diffusphere™ in connection with the drug delivery process; the advancement of opportunities stemming from Diffusphere™ and the expansion of pipeline designs; the benefits to patients from the Company's drug platforms; the translation of the Company's technologies and expansion of its offerings into clinical applications; and the use of the terms "EP-104IAR", "EP-104GI", and "EP-104" in future disclosure.

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 health pandemics 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). 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.