Met primary and three key secondary endpoints
Data support clinically meaningful and durable pain relief
Pharmacokinetic and safety data support potential for chronic and bilateral dosing
Company to host conference call at 11:00 a.m. ET today
VICTORIA, BC, June 26, 2023 /PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company with an innovative drug delivery platform, today announced positive results from its Phase 2b clinical trial of EP-104IAR for pain associated with knee osteoarthritis ("OA"). EP-104IAR met its primary endpoint with a clinically meaningful and statistically significant (p=0.004) improvement over vehicle-placebo in WOMAC Pain at 12 weeks.
EP-104IAR also showed statistically significant improvement over placebo at 12 weeks in three of four secondary endpoints: WOMAC Function (p=0.014), OMERACT-OARSI strict responders (p=0.011) and Area Under the Curve (AUC) for WOMAC Pain (p<0.001). Importantly, statistical significance with OMERACT-OARSI strict responders to 15 weeks and AUC for WOMAC Pain to 24 weeks was also seen in the Phase 2b study, highlighting a strong and durable response. The secondary endpoint of the difference in change from baseline in the WOMAC Pain subscale at 24 weeks was not met, delivering statistical significance to 14 weeks.
The Company also performed pre-specified analyses in the moderate sub-population which comprised 68% of the study population (n=214). Statistically significant efficacy was seen for WOMAC Pain (17 weeks) and OMERACT-OARSI strict responders (22 weeks). Additionally, 40% of moderate patients achieved near complete pain relief (WOMAC Pain score of ≤2) which was statistically significant for 22 weeks.
EP-104IAR was well tolerated, with adverse events similar to placebo, and no withdrawals due to drug side effects. Changes in cortisol were minimal and transient and there were no differences in blood glucose levels between treatment groups, including diabetics. The Company believes these safety data and the observed pharmacokinetic profile support Eupraxia's goal of developing a product that can be used for repeat and bilateral dosing, and in certain at-risk populations.
"We are ecstatic about these results," said Dr. James Helliwell, CEO of Eupraxia. "Our objective from the beginning was to design a product that provides prolonged duration with a compelling safety profile that may allow for repeat and bilateral dosing. We believe these Phase 2b results move us closer towards that goal, which could potentially change the OA treatment paradigm. If approved, this represents a significant opportunity to treat millions of underserved patients. In addition, these data provide further validation of our technological platform and the potential for its use in other indications."
"I am very impressed with these data," said Dr. Lee Simon, Board Certified Rheumatologist and former FDA Division Director. "To have statistically significant and clinically meaningful effects on pain, together with a compelling safety profile, supports EP-104IAR's potential in OA. EP-104IAR's efficacy profile, durability of response, and tolerability suggest the product has the potential to be an important new therapy compared to currently available osteoarthritis treatments."
Based on these compelling results, Eupraxia intends to aggressively pursue its Phase 3 development program. The Company's recently granted Fast Track designation from the FDA for EP-104IAR recognizes the significant unmet medical need in this prevalent disease.
About Phase 2 Protocol EP-104IAR-201
EP-104IAR-201 was a randomized, double-blind, vehicle-controlled study of 318 knee OA patients (163 EP-104IAR, 155 vehicle-placebo) with Kellgren-Lawrence grade (2-3) and moderate to severe pain scores as evaluated by the WOMAC Pain (4-9). The study was conducted at 12 sites in Denmark, Poland and the Czech Republic.
The primary endpoint met in the study was the difference in change from baseline between EP-104IAR and placebo (vehicle control) in WOMAC Pain score at 12 weeks.
Secondary endpoints met included:
The difference in change from baseline in the WOMAC Function subscale at 12 weeks
The difference in the area under the curve of the WOMAC Pain subscale at 12 weeks
The difference in Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) strict responders at 12 weeks
About EP-104IAR and OA
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 endeavours 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 long-duration 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. The product 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.
Conference Call Details
Eupraxia management intends to host a conference call and webcast today, June 26, 2023, to discuss the trial results further.
Date: Monday, June 26, 2023
Time: 11:00 a.m. ET
Dial-in Numbers: (416) 764-8650 or (888) 664-6383
Conference ID: 81782172
Rapid Connect:
Webcast: webcast will also be available on the Events and Presentations page of the Company's investor website.
Replay: (416) 764-8677 or (888) 390-0541 (playback code: 782172 #). Available until midnight (ET) on July 3, 2023.
About Eupraxia Pharmaceuticals Inc.
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: .
Notice Regarding Forward-looking Statements and Information
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 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, effectiveness, and tolerability; the results gathered from studies of Eupraxia's product candidates and their potential support for dosing and target population; the Company's intention to pursue its Phase 3 development; the Company's beliefs with respect to the treatment of knee OA pain; 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 its 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 (). 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.
