Eupraxia Pharmaceuticals Doses First Patient in Phase 1b/2a Eosinophilic Esophagitis Trial
VICTORIA, BC, June 8, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has commenced dosing patients in its phase 1b/2a trial that is evaluating EP-104GI's safety, tolerability and efficacy as a treatment for eosinophilic esophagitis ("EoE").
"Dosing the first patient in our EoE trial is a significant achievement for the Company's clinical team and an important step towards realizing the therapeutic potential of this product candidate for a condition with significant unmet medical need," said Dr. James Helliwell, CEO of Eupraxia. "We are excited to move this program forward rapidly and establish proof of concept in patients this year. Given that this is an open-label study, we expect to begin reporting results by cohort in the second half of 2023. Together with our phase 2 study of EP-104IAR in osteoarthritis of the knee, we expect to report a meaningful volume of mid-stage clinical data for our product candidate across two indications in 2023."
EoE is a chronic, immune-mediated condition of the esophagus that causes inflammation, structural damage and dysfunction when left untreated. It is characterized as an "orphan disease" – a rare condition that affects fewer than 200,000 people in the United States, and for which exists significant unmet medical need.
Current EoE treatment options, which include diet changes, proton pump inhibitor therapy, slowly dissolving oral steroid tablets, monoclonal antibodies, and/or mechanical endoscopic dilation, often provide poor or temporary control over the condition.
Oral administration of steroids, including fluticasone propionate, can provide short-term relief. But prolonged use of these formulations, often prescribed off-label, can lead to other conditions such as candidiasis (thrush) in the mouth and esophagus, and ultimately poor patient compliance and disease control.
EP-104 represents an opportunity to inject long-acting fluticasone propionate directly into the affected tissues of a patient's esophagus utilizing the Company's drug delivery technology platform, with the potential for extended duration of effect, optimized drug kinetics and an improved safety profile.
The Company's technology platform, which encapsulates fluticasone propionate, uses a novel polymer membrane designed to release drug at a pre-defined rate and could result in an effective, sustained treatment for EoE, improving patient outcomes.
- Eupraxia's phase 1b/2a trial for EoE is an open-label, single ascending-dose study assessing patients one and three months post treatment.
- The trial's target enrollment is up to 15 patients enrolled from centres in Canada, the Netherlands and Australia.
- 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 EoE trial will begin with a low-dose cohort to assess pharmacokinetics of the delivery methodology. As the trial progresses, escalating doses may be given in subsequent cohorts to optimize patient outcomes, identify duration of the treatment and assess safety.
- The trial's primary endpoint is a clinically significant reduction of eosinophils, which are specialized white blood cells that curb infection and boost inflammation. The trial will also assess the functional improvement of patients with EoE.
- Eupraxia intends to pursue orphan drug status and any other mechanisms that could accelerate clinical testing and regulatory submission for EoE.
Eupraxia also continues to advance its ongoing phase 2 trial evaluating EP-104IAR's safety and efficacy as a treatment for knee osteoarthritis ("OA") and expects to report top-line trial results in the second quarter of 2023.
Eupraxia's lead product candidate, EP-104, 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, such as EoE and OA.
EP-104 is comprised of a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.
Many drugs have the potential to work well but are limited by the way they are delivered. This can lead to unwanted side effects, poor efficacy, and a short duration of action.
Eupraxia's polymer-based proprietary technology aims to provide better therapy by potentially delivering the right dose of drug, in the right place, for the right amount of time.
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-104 platform has expanded into gastrointestinal disease with the launch of a phase 2 program to treat 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 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 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 1b/2a trial, including assessment objectives and expected timing with respect to the reporting of results and trial completion; the anticipated dosage used in the phase 1b/2a trial; the Company's intention to pursue orphan drug status or other mechanisms; statements regarding the Company's phase 2 trial, including ongoing advancement and expected timing with respect to the reporting of results; the potential of Eupraxia's product candidates, including EP-104's potential to treat EoE and OA and its differentiation from other drugs; the Company's expectations regarding its product designs, including with respect to targeted shelf life, storage, ease of integration, duration, tolerability, effectiveness and safety; 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; 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 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.
For investor and media inquiries, please contact:
Danielle Egan, Eupraxia Pharmaceuticals Inc.
Adam Peeler, on behalf of:
Eupraxia Pharmaceuticals Inc.
SOURCE Eupraxia Pharmaceuticals Inc.
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