Eupraxia Pharmaceuticals Announces Positive Clinical Data in EP-104GI RESOLVE Trial
- Initial low dose presents early efficacy signals
- Second cohort now fully dosed at twice the initial dose
- Further results to be disclosed in Q1 2024
VICTORIA, BC, Dec. 12, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company, today announced positive clinical data from its Phase 1b/2a RESOLVE trial, which is evaluating safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis ("EoE").
"The data announced today from our RESOLVE trial in EoE demonstrate early efficacy signals from patients treated with EP-104GI," said Dr. James Helliwell, CEO of Eupraxia. "EoE is a chronic, immune-mediated condition of the esophagus that causes inflammation, structural damage and dysfunction when left untreated. It adversely affects patients and burdens the healthcare system, as current treatment options often provide poor or temporary control over the condition. We believe that EP-104GI has the potential to become an important treatment for EoE."
The results announced today from the first cohort of the RESOLVE trial, treating EOE using Eupraxia's Diffusphere™ technology, are derived from a low initial dose of four 1 mg injections of EP-104GI injected in a small portion of each patient's lower esophagus.
The data indicate efficacy signals at this initial, low dose. The cohort's first patient had very severe disease in the distal esophagus (where the injections were given) and on entry into the trial had severe difficulty swallowing (dysphagia), and significant pain on swallowing (odynophagia) with frequent bouts of vomiting. Within two weeks, these symptoms had been reduced significantly. This patient has maintained this high degree of response until week 12 of the trial where they remain asymptomatic.
The other two patients in this cohort had diffuse disease throughout the esophagus (far away from where the injection occurred) and therefore Eupraxia did not expect any clinical response. Both patients showed meaningful improvement in their dysphagia and odynophagia scores after treatment in addition to improvements in their Strauman Dysphagia Index scores. Histology results in all patients are inconclusive in this first cohort.
These results from the first cohort of a very low dose of EP-104GI in a small area of the esophagus has resulted in meaningful symptom improvement in all patients to at least 12 weeks. This response is believed to be indicative of the potential for higher doses to spread more diffusely through the esophagus and provide a more pronounced and prolonged response in this difficult-to-treat population.
The Company has previously announced that based on its first external safety review meeting of the RESOLVE trial, the original timeline of the trial was extended to six months to fully characterize the duration of efficacy. As is evident by the continued meaningful improvement at three months in this first cohort with a low dose, Eupraxia is looking forward to following patients in this and subsequent cohorts to six months.
The second cohort of the RESOLVE trial has been fully recruited and the dosing doubled from the initial cohort, with eight 1 mg injections offering broader coverage of the esophagus. The trial's second cohort has now been fully dosed and further results are expected in the first quarter of 2024.
The Company anticipates also releasing additional interim data as the study progresses.
RESOLVE is a Phase 1b/2a open-label trial with the primary objectives set to evaluate the safety and pharmacokinetic profile of EP-104GI when administered to the esophagus. The trial also includes a secondary objective to evaluate the efficacy of EP-104GI on EoE disease activity as measured by symptoms, endoscopy, and histology. RESOLVE is an unblinded, dose-ascending trial consisting of three patients per cohort and a maximum of five cohorts for a total target enrollment of up to 24 patients enrolled from centres in Canada, the Netherlands and Australia.
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 that delivers targeted, long-lasting activity with fewer side effects. Diffusphere™, a proprietary, polymer-based micro-sphere technology, facilitates targeted drug delivery, with extended duration of effect, and offers multiple, highly tuneable PK profiles. The technology can be used 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 osteoarthritis of the knee. EP-104IAR met its primary endpoint and three of the four secondary endpoints. The EP-104 platform has expanded into gastrointestinal disease and has initiated a Phase 1b/2a 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" 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, including with respect to the potential for higher doses; the ability of the Company to execute on its business strategy; the potential of Eupraxia's product candidates, including EP-104GI with respect to the treatment of EoE; 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 the timing of release thereof, including with respect to the RESOLVE trial; 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; and the use of the terms "EP-104IAR", "EP-104GI", and "EP-104" in future disclosure.
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 the COVID-19 pandemic 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+ (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.
SOURCE Eupraxia Pharmaceuticals Inc.
For investor and media inquiries, please contact: Danielle Egan, Eupraxia Pharmaceuticals Inc., 778.401.3302, [email protected] or Adam Peeler, on behalf of: Eupraxia Pharmaceuticals Inc., 416.427.1235, [email protected]
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