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Eupraxia Pharmaceuticals Announces Sustained Positive Treatment Outcomes in Patients with Eosinophilic Esophagitis (EoE) After Nine Months of Receiving EP-104GI
Globenewswire· 2025-05-05 11:00
Core Insights - Eupraxia Pharmaceuticals announced positive outcomes from its RESOLVE Phase 1b/2a trial for EP-104GI, showing sustained or improved treatment results in all three patients after nine months of therapy [1][3][4] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing drug delivery systems for unmet medical needs, utilizing its proprietary DiffuSphere™ technology [16][17] - The company is currently evaluating EP-104GI for eosinophilic esophagitis (EoE), a chronic inflammatory condition affecting the esophagus [1][15] Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [12] - Cohort 5 data revealed that patients receiving 48 mg of EP-104GI showed significant improvements in symptom severity, tissue health, and eosinophil counts after nine months [3][4][5] Key Findings - Symptom Improvement: Patients reported an average reduction of 3.7 points (65%) on the Straumann Dysphagia Index (SDI) after nine months [4][6] - Tissue Health: There was a 56% average reduction in EoEHSS Stage score and a 45% reduction in Grade score [4][5] - Eosinophil Reduction: A mean decrease of 77% in eosinophil counts was observed, with a 52% remission rate across biopsy sites [5][6] Future Plans - Additional long-term data with higher doses is expected to be released in Q3 2025 [3][13] - The company will host a webinar on May 9, 2025, to discuss the RESOLVE trial data [11]
Eupraxia Pharmaceuticals to Present at Investor and Scientific Conferences in April and May
Newsfilter· 2025-04-24 21:00
Core Viewpoint - Eupraxia Pharmaceuticals Inc. is actively participating in multiple upcoming investor and scientific conferences to present its clinical data and advancements in drug delivery technology, particularly focusing on its proprietary DiffuSphere™ technology and ongoing clinical trials for its product candidates [1][9]. Conference Presentations - The company will present at the Osteoarthritis Research Society International World Congress from April 24-27, 2025, with a poster on EP-104IAR, highlighting sustained pain response in knee osteoarthritis patients [2][3]. - At the Digestive Disease Week Annual Meeting from May 3-6, 2025, data from the Phase 1b study of EP-104GI for eosinophilic esophagitis will be presented, including results from the ongoing RESOLVE trial [4][5]. - The CEO will present at the Bloom Burton & Co. Healthcare Investor Conference on May 5, 2025, and participate in investor meetings [5][6]. Product Development - Eupraxia's EP-104GI is in a Phase 1b/2a trial for eosinophilic esophagitis, utilizing a unique local delivery method via injection into the esophageal wall [10]. - The company recently completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints, indicating potential for effective treatment in knee osteoarthritis [10]. Technology Overview - The DiffuSphere™ technology is designed for targeted drug delivery, aiming to improve the safety, tolerability, efficacy, and duration of effect of existing and novel drugs, with applications extending beyond pain and inflammatory gastrointestinal diseases to oncology and infectious diseases [9][10].
Eupraxia Pharmaceuticals Reports Fourth Quarter 2024 Financial Results
Prnewswire· 2025-03-20 21:31
Core Insights - Eupraxia Pharmaceuticals Inc. reported financial results for Q4 2024, highlighting a net loss reduction and successful clinical trial data for its product EP-104GI [1][4][2] Financial Performance - The company incurred a net loss of $7.5 million in Q4 2024, an improvement from a net loss of $10.6 million in Q4 2023, attributed to lower research and development costs and reduced expenses [4] - Cash reserves increased to $33.1 million as of December 31, 2024, up from $19.3 million at the end of Q4 2023, providing sufficient funding for clinical trials and operational needs into Q3 2026 [5] Clinical Developments - Positive data from the Phase 1b/2a RESOLVE trial for EP-104GI indicated improved tissue health and symptom reduction in eosinophilic esophagitis patients, with higher doses showing better outcomes [2][13] - The company also completed a Phase 2b trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints [13] Operational Highlights - The appointment of Dr. Amanda Malone as Chief Operating and Scientific Officer was announced, along with the return of Alex Rothwell as Chief Financial Officer [6] - The company presented significant trial data at various medical conferences, receiving accolades for its research quality [6] Market and Trade Considerations - Management is monitoring the potential impact of proposed tariffs on Canadian goods by the U.S. government and retaliatory tariffs from Canada, assessing their implications for the company's operations [8][10] - Eupraxia sources its active pharmaceutical ingredients from the U.S. and maintains U.S. dollar balances to mitigate exchange rate fluctuations [9]
Eupraxia Pharmaceuticals Announces Positive Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Prnewswire· 2025-02-25 12:00
Core Insights - Eupraxia Pharmaceuticals announced positive clinical data from its ongoing RESOLVE Phase 1b/2a trial for EP-104GI, aimed at treating eosinophilic esophagitis (EoE) [1][3] - The trial has shown improvements in both tissue health and symptom relief, with no serious adverse events reported [3][5] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on precision local drug delivery, particularly for conditions with high unmet medical needs [14][15] - The company utilizes its proprietary DiffuSphere™ technology to facilitate targeted drug delivery, aiming to improve safety and efficacy compared to traditional methods [14] Clinical Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study evaluating the safety and efficacy of EP-104GI in adults with active EoE [9] - Cohort 6 of the trial received 16 injections of 4 mg EP-104GI, targeting the lower three-quarters of the esophagus, resulting in significant improvements in symptom relief and tissue health [4][5] Key Findings from the RESOLVE Trial - Cohort 6 demonstrated the highest symptom relief scores (SDI) and the greatest improvement in tissue health scores (EoEHSS) to date [5][6] - A mean reduction of 94% in peak eosinophil counts (PEC) was observed, with a 62% remission rate across biopsy sites [6][8] - No serious adverse events or cases of oral or gastrointestinal candidiasis were reported in any of the cohorts [5][6] Future Expectations - Cohort 7 is fully enrolled, with 12-week data expected in late Q2 2025 [10] - The company plans to explore higher dosing levels and expanded esophageal coverage in future cohorts based on the positive outcomes observed [3][5]
Eupraxia's DiffuSphere™ Technology Demonstrates Targeted Drug Release while Minimizing Systemic Exposure for a Period of More Than Six Months
Prnewswire· 2024-11-20 12:00
Core Insights - Eupraxia Pharmaceuticals Inc. has introduced new pharmacokinetic data from its Phase 2a Eosinophilic Esophagitis program, highlighting the capabilities of its DiffuSphere™ platform for precise drug delivery [1][4][9] Group 1: DiffuSphere™ Technology - DiffuSphere™ enables targeted drug delivery with a flat, stable, and long-lasting release profile, minimizing adverse effects associated with conventional drug delivery methods [2][17] - The technology consists of a pure drug crystal encased in a polymer shell, allowing for controlled release and high concentrations in target tissues while reducing systemic exposure [3][17] - Clinical trials have demonstrated that a single injection of DiffuSphere™ can maintain therapeutic drug levels for over six months, significantly improving treatment outcomes for conditions like eosinophilic esophagitis and osteoarthritis [5][6] Group 2: Clinical Trial Results - In the RESOLVE trial, DiffuSphere™ showed a treatment duration exceeding six months with a steady drug level of 1.5 pg/ml maintained in patients receiving 4 mg of fluticasone propionate [5] - The Phase 2b study of EP-104IAR for osteoarthritis demonstrated significant pain relief for up to 22 weeks, with no adverse effects on blood glucose metabolism or adrenal function [6][12] - Eupraxia's clinical data supports the efficacy of DiffuSphere™ in improving key disease measures, including patient symptoms and tissue health [5][9] Group 3: Broader Applications - DiffuSphere™ has shown versatility across various drug classes and anatomical locations, including intraarticular, intraesophageal, and intravitreal applications [8][17] - The technology has been successfully tested with local anesthetics and anti-infective agents, indicating its potential for diverse therapeutic uses [8][17] - Eupraxia aims to leverage DiffuSphere™ for future treatments in oncology and infectious diseases, expanding its application beyond pain and inflammatory gastrointestinal diseases [17][18]
Eupraxia Pharmaceuticals to Present at American College of Rheumatology Convergence 2024 Annual Meeting
Prnewswire· 2024-11-14 22:00
Core Insights - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on optimizing drug delivery through its proprietary DiffuSphere™ technology, which addresses significant unmet medical needs [1][5] - The company will present a poster at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting, highlighting its research on EP-104IAR, a long-acting intra-articular injection for osteoarthritis [1][4] Company Overview - Eupraxia specializes in developing locally delivered, extended-release products aimed at therapeutic areas with high unmet medical needs [5] - The DiffuSphere™ technology is designed to facilitate targeted drug delivery, potentially improving safety, tolerability, efficacy, and duration of effect compared to traditional methods [5] Event Details - The ACR Convergence 2024 Annual Meeting will take place in Washington, D.C. from November 14-19, 2024, providing a platform for education and research in rheumatology [3] - Eupraxia's poster presentation will focus on the sustained improvement in pain for subjects with moderate baseline pain and BMI less than 30, based on a Phase 2 study [4]
Eupraxia Pharmaceuticals' CEO Dr. James Helliwell to Participate in Webinar Event, "Eosinophilic Esophagitis: The Emerging Digestive Disorder Frequently Misdiagnosed", on November 15, 2024
Prnewswire· 2024-11-13 22:00
Core Insights - Eosinophilic Esophagitis (EoE) is a rapidly increasing digestive disorder affecting over 450,000 people in the United States, leading to significant healthcare burdens and mental health issues [3][4]. Company Overview - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products to address high unmet medical needs [4]. - The company utilizes its proprietary DiffuSphere™ technology for optimized drug delivery, aiming to improve safety, tolerability, efficacy, and duration of effect for existing and novel drugs [4]. Product Development - Eupraxia's EP-104GI is currently in a Phase 1b/2a trial (RESOLVE trial) for treating EoE, utilizing a unique injection method for local drug delivery [5]. - The company has also completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, targeting pain from knee osteoarthritis, achieving its primary endpoint and three of four secondary endpoints [5]. - Eupraxia is developing a pipeline of long-acting formulations for various indications, including inflammatory joint diseases and oncology [5]. Upcoming Events - Eupraxia's CEO, Dr. James A. Helliwell, will present at a Tribe Public Webinar on November 15, 2024, discussing EoE and its implications [1][2].
Eupraxia Pharmaceuticals Announces Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Prnewswire· 2024-11-12 22:56
Core Insights - Eupraxia Pharmaceuticals Inc. announced positive clinical data from its RESOLVE Phase 1b/2a trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE) [2][4] Group 1: Clinical Trial Results - In the fifth cohort of the RESOLVE trial, one patient achieved complete histological remission at 12 weeks, with a significant reduction in eosinophils [3] - All six evaluable patients in the fourth and fifth cohorts reported improved symptoms, with a 41% mean reduction in the Straumann Dysphagia Index (SDI) scores at 12 weeks [3][4] - The fourth cohort showed the largest average reduction in SDI scores to date, with a four-point reduction at 24 weeks [6] - The fifth cohort demonstrated the greatest percentage change in histology scores, with a peak reduction of 100% in Stage and Grade scores and a mean 54% reduction in Composite Stage and Grade scores [3][4] Group 2: Safety and Efficacy - No serious adverse events have been reported across all five cohorts, indicating a favorable safety profile for EP-104GI [3][4] - Plasma fluticasone levels remained predictable and well below those seen in daily fluticasone asthma treatments, with no adverse events such as candidiasis or adrenal suppression reported [4] - The trial is designed as a multicenter, open-label, dose-escalation study, assessing safety, tolerability, pharmacokinetics, and efficacy of EP-104GI [4][10] Group 3: Future Developments - Cohort 6 is fully enrolled and dosed, with 12-week data expected in Q1 2025 [3] - The company plans to periodically disclose additional data from the RESOLVE trial [5]
Eupraxia Pharmaceuticals Inc(EPRX) - 2024 Q3 - Quarterly Report
2024-11-07 22:17
Exhibit 99.1 EUPRAXIA PHARMACEUTICALS INC. CONSOLIDATED FINANCIAL STATEMENTS For the Three and Nine Months ended September 30, 2024 (Unaudited and Expressed in U.S. Dollars) EUPRAXIA PHARMACEUTICALS INC. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (Unaudited and Expressed in U.S. Dollars) CONTENTS | CONSOLIDATED BALANCE SHEETS | 2 | | --- | --- | | CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | 3 | | CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) | 4-5 | | CONSOL ...
Eupraxia Pharmaceuticals Reports Third Quarter 2024 Financial Results
Prnewswire· 2024-11-07 22:00
Core Insights - Eupraxia Pharmaceuticals Inc. reported its financial results for Q3 2024, highlighting advancements in clinical trials and financial activities [1][2] Clinical Developments - The company advanced its Phase 1b/2a RESOLVE trial for EP-104GI, showing positive results for eosinophilic esophagitis and presenting data at international medical conferences [2][3] - The Phase 2b SPRINGBOARD trial data for EP-104IAR in knee osteoarthritis was published in The Lancet Rheumatology, indicating significant clinical progress [2][3] Financial Performance - Eupraxia incurred a net loss of $6.0 million for Q3 2024, an increase from $4.9 million in Q3 2023, primarily due to reduced other income from changes in financial instruments [4] - Cash reserves decreased to $8.7 million as of September 30, 2024, down from $19.3 million at the end of Q4 2023, with funds allocated for clinical trials and general corporate purposes [5] Funding and Future Outlook - The company raised C$44.5 million through a non-brokered private placement, which, along with existing cash reserves, is expected to fund operations through Q3 2026 [6] - As of September 30, 2024, the company had 35,622,553 common shares outstanding [6] Management Changes - The company strengthened its management team by appointing Dr. Amanda Malone as Chief Operating and Scientific Officer and Dr. Rahul Sarugaser as Executive Vice President of Corporate Development [3]