Management mitigating risk by adding clinical sites in two countries and making protocol changes
Timing for top-line results remains unchanged, still expected in Q4 2022
VICTORIA, BC, Dec. 2, 2021 /CNW/ - December 2, 2021 - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company with an innovative drug delivery platform technology, today provided an update on its ongoing Phase 2 trial that is evaluating the safety and efficacy of its drug candidate EP-104IAR as a treatment for knee osteoarthritis.
The Company is expanding its clinical trial locations to two additional countries to facilitate more rapid and consistent patient screening in a constantly evolving pandemic environment. Eupraxia anticipates that costs associated with expanding the number of trial sites will be immaterial. In addition, several updates have been initiated in the trial's protocol to facilitate more rapid patient screening.
"As the COVID-19 pandemic continues to place pressure on clinical trial execution around the world, and the situation evolves across Europe, including Denmark, we believe it is prudent to proactively take steps to further mitigate risk in our trial in response to these challenges," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "While we are actively dosing patients, management believes these changes will help build on the patient enrolment progress made to date and continue to support our target for top-line data readout at the end of 2022. In addition, we are maintaining our focus on the high quality of the trial and remain uncompromising on the rigour of our protocol."
More information on the Company's Phase 2 trial, including new site locations will be available here:
Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee OA. The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. 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 the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration but can expose the body to unwanted local and systemic side effects.
EP-104IAR is being developed to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane.
Injected into the knee, EP-104IAR is intended to slowly release drug at therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees.
EP-104IAR has completed a Phase 1 trial and is currently in Phase 2 clinical development. A modified version of EP-104IAR is under development for canine and equine OA.
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 OA of the knee. In addition to EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as post-surgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. Eupraxia is also developing a formulation of EP-104IAR for use in canine and equine OA.
For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com
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 press release include statements regarding the expansion of the Company's clinical trial locations and the materiality of the associated costs with such expansion; the Company's business strategies and objectives, including current and future plans and the Company's ability to move into Phase 3 development, expectations and intentions, statements regarding the Company's Phase 2 clinical trial, including the expected timing for dosing patients in the Phase 2 trial, expected timing of the data readout and the results thereof, the ability of the Company to execute on its business strategy, the Company having sufficient resources, the potential 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, the translation of the Company's technologies and expansion of its offerings into clinical applications, the Company's estimation of potential product markets, the demand and market acceptance for products developed by the Company and the impact of COVID-19 on the Company's ability to meet expectations, intentions and expected timelines with respect to its Phase 2 clinical trial. 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 ability of the Company to meet its intended timing for the dosing of patients in its Phase 2 trial, the ability of the Company to meet its timeline of its data readout from its Phase 2 trial in late 2022, 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 nonclinical 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.
SOURCE Eupraxia Pharmaceuticals Inc.
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