• EP-104IAR demonstrates trends to reduction in joint inflammation and improvement in cartilage quality and morphology compared to placebo

VICTORIA, BC, Jan. 30, 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 positive magnetic resonance imaging ("MRI") data from the Company's ongoing SPRINGBOARD Study, a Phase 2 randomized, double-blind, vehicle-controlled, parallel-group trial evaluating the safety and efficacy of EP-104IAR for the treatment of osteoarthritis ("OA") of the knee (NCT04120402).

"The positive results from the MRI sub-study of the SPRINGBOARD trial provide supportive clinical evidence that treatment with EP-104IAR does not appear to negatively impact cartilage health or exacerbate inflammatory conditions in the surrounding area, which is important information that supports continued clinical development of EP-104IAR," said Dr. James Helliwell, CEO of Eupraxia. 

The clinical data are based on the 12-month results from an MRI sub-study where subjects from the SPRINGBOARD study were invited to participate in an optional imaging analysis that was performed in parallel to data collection for the main study. MRI, including Dynamic Contrast Enhanced scans of the index knee and T2 Scans, were obtained as part of this sub-study. These MRI analyses included assessments of synovial inflammation (synovial thickness, synovial blood flow) and articular cartilage health (cartilage quality and morphology) for EP-104IAR versus placebo. Cartilage health, quality and morphology, were assessed by T2 relaxation times, which can indicate deterioration of the collagen network and increased water content. Changes in T2 values may show subtle changes in cartilage composition even before structural changes appear. Due to the planned small subject numbers per treatment arm, these images were not expected to provide statistically significant data.

In the SPRINGBOARD study, 318 subjects with knee OA pain were randomized 1:1 to receive a single intra-articular dose of EP-104IAR 25mg (n=163), or vehicle (n=155) in one index knee and were followed for 24 weeks. The study enrolled male and females, ≥40 years, diagnosed with primary knee OA with a Kellgren-Lawrence Grade 2 or 3, OA symptoms for ≥6 months and weekly WOMAC® Pain scores ≥4.0 to ≤9.0 (out of 10), which did not vary by >3 points. WOMAC Pain, Stiffness and Function (0-10 scales) were collected for the index knee weekly (pain) and monthly (stiffness/function) via e-diary. Baseline was the average of three pain scores during the two-week baseline period or a single pre-dose score for stiffness and function.

In parallel to the main study, MRI (with macrocyclic gadolinium-based contrast agent) of the index knee was obtained from participating patients who received EP-104IAR (n=6) or placebo (n=6). Scans were performed at baseline and weeks 12, 24 and 52 (or on early exit). Following completion of assessments for the main study at week 24, patients were treated as necessary, using the standard of care, by their physician. All MRI central readers were blinded to treatment allocation and study visit.

The data obtained in the MRI sub-study demonstrated the following results:

• Treatment with EP-104IAR resulted in a decrease in inflammation at weeks 12 and 24 when compared to placebo.  The two groups were similar at one year as the clinical effect of the single EP-104IAR injection had waned by one year.
•  A correlation between reduction in inflammation and a reduction in WOMAC Pain scores was observed.
• A trend of equivalent or improved T2 relaxation times was observed in the EP-104IAR treated group compared to the placebo group at 12 weeks and that trend held steady, or improved, at 24 weeks and 52 weeks. This data suggests a trend of potential improvement in cartilage quality and morphology in the treated group.

These exploratory data will provide guidance on the value of including further MRI assessments as part of the Company's EP-104IAR clinical program. Eupraxia has previously published data demonstrating preservation of cartilage quality and morphology to 10 months with EP-104IAR in GLP toxicology studies in dogs; the data discussed today is the first human data to support potential reduction of inflammation and preservation of cartilage quality in humans with EP-104IAR.

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's lead product candidate, EP-104IAR, recently completed a Phase 2b clinical trial for the treatment of pain due to OA of the knee. EP-104IAR 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 to treat 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", "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 MRI sub-study and Phase 2 clinical trials; the ability of the Company to execute on its business strategy; the potential of Eupraxia's product candidates, including EP-104IAR and EP-104GI and their respective proposed indications; the Company's expectations regarding its product designs, including with respect to patient benefit, duration, safety, effectiveness and tolerability; the results gathered from studies of Eupraxia's product candidates, including with respect to data obtained from the MRI sub-study; 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, the use of the terms "EP-104IAR", "EP-104GI", and "EP-104" in future disclosure; and other statements that are not historical in nature.

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+ (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.