"EP-104IAR is designed to precisely deliver therapeutic levels of injected fluticasone propionate over an extended duration, which may help overcome some of the limitations of traditional oral steroids and provide longer and more stable disease remission and an improved quality of life for patients with EoE," said Dr. James Helliwell , CEO of Eupraxia. "On that basis, we are initiating a Phase 2, open-label clinical study in adult patients with data from the trial expected to begin reading out in the first half of 2023."
The Company believes its drug delivery technology platform has the potential to be effective in EoEÂ based on the proven efficacy of oral immediate release fluticasone propionate in this indication, and the growing library of data supporting the value of extended-release steroids in a variety of indications. The Company's technology is underpinned by a novel polymer membrane designed to release drug at a pre-defined rate, which could result in an effective, sustained treatment for EoE, improving patient outcomes.
Eupraxia has received regulatory clearance in Canada and the Netherlands , with responses pending from additional jurisdictions. The Company believes that this expansion of its clinical-stage pipeline represents the opportunity to further demonstrate the value of its platform across multiple indications. Eupraxia is continuing to pursue additional drug candidates and therapeutic targets, with a specific focus in oncology.
About EoE
EoE is a chronic, immune mediated condition of the esophagus that causes inflammation, structural damage and dysfunction. It is characterized as an "orphan disease" – a rare condition that affects fewer than 200,000 people in the United States and/or 5 in 10,000 Europeans, and for which exists significant unmet medical need.
Current EoE treatment options (including diet changes, drugs such as proton pump inhibitors designed to help block acid build-up, and topical steroids that are swallowed to help reduce swelling and inflammation, and surgical dilation) often provide poor or only temporary control over the condition. Oral administration of steroids, including fluticasone propionate, can provide short-term relief, but prolonged use of these formulations, which are often prescribed off-label, leads to other conditions, such as candidiasis (thrush) in the mouth and esophagus, and ultimately poor patient compliance and disease control. In contrast, EP-104IAR poses the opportunity to inject long-acting fluticasone propionate directly into the affected tissues, with the potential for extended duration of effect, optimized drug kinetics and an improved safety profile.
Clinical Strategy
EP-104IAR is currently being evaluated in a multi-centre European Phase 2 study focused on patients with osteoarthritis of the knee. This program includes significant and on-going pre-clinical data on EP-104IAR, allowing the EoE Phase 2 study to commence immediately in patients. The EoE study will assess the safety, tolerability and potential efficacy of endoscopically targeted injections of fluticasone propionate into affected areas of the esophagus. The Phase 2 trial in EoE will begin with a low dose to assess to pharmacokinetics of the delivery methodology. As the trial progresses, escalating doses may be given to optimize patient outcomes and duration of the treatment. The study will be conducted in multiple jurisdictions, including Canada and the Netherlands .
Eupraxia intends to pursue orphan drug status and any other mechanisms that could accelerate clinical testing and ultimate regulatory submission for EoE.
About EP-104IAR
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 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 late in the disease but can expose the body to unwanted local and systemic side effects.
EP-104IAR endeavours 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, part of Eupraxia's patented technology platform.
Injected into the knee, EP-104IAR is intended to diffuse drug slowly into the knee joint providing 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 by allowing simultaneous treatment of both affected joints.
In contrast to immediate release steroids, a non-clinical study of EP-104IAR suggests a cartilage sparing effect, which could provide a safer treatment alternative for those afflicted with chronic OA pain. The product has also been designed with physician convenience in mind – targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.
The potential advantages of EP-104IAR are central to the expansion into EoE and other indications. EoE is a localized inflammatory disease of the esophagus that has relied primarily on swallowing steroids (often off-label compounded versions) to control disease symptoms. Eupraxia hopes that a localized administration of an extended-release steroid will offer patients an effective treatment option that lasts for months instead of hours.
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. The EP-104IAR platform is expanding into gastrointestinal disease with the launch of a program to treat EoE. 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 postsurgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. 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", "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 press release include statements regarding the Phase 2 trial of EP-104IAR in patients afflicted with EoE, including the expected outcome of the Phase 2 trial, the expected timing of data from the Phase 2 trial and the receipt of regulatory clearance from additional jurisdictions; the potential and potential benefits of EP-104IAR; 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 Company having sufficient resources, including anticipated funding from its current cash runway;  the potential of Eupraxia's product candidates; the Company's expectations regarding its product designs, including with respect to targeted shelf life, storage and ease of integration; 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; the translation of the Company's technologies and expansion of its offerings into clinical applications; the Company's estimation of potential product markets; and the demand and market acceptance for products developed by the Company. 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 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.
SOURCE Eupraxia Pharmaceuticals Inc.
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