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About Eupraxia Pharmaceuticals Inc. (EPRX)
Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology to develop locally delivered, extended-release pharmaceuticals that address significant unmet medical needs. The company is headquartered in Victoria, British Columbia, and is publicly traded on both the Toronto Stock Exchange (TSX: EPRX) and NASDAQ (EPRX).
Core Business Areas
Eupraxia focuses on precision drug delivery systems designed to optimize therapeutic outcomes by targeting specific tissues with minimal systemic exposure. Its lead product candidates include:
- EP-104IAR: A long-acting formulation for the treatment of pain associated with osteoarthritis of the knee. This product has demonstrated clinically significant and durable pain relief in Phase 2 trials, with a strong safety profile and minimal systemic side effects.
- EP-104GI: A novel treatment for eosinophilic esophagitis (EoE), an inflammatory condition of the esophagus. The RESOLVE Phase 1b/2a trial has shown promising results, including improved tissue health and symptom reduction, without significant adverse effects.
Proprietary Technology: DiffuSphere™
Eupraxia's innovative DiffuSphere™ technology is a polymer-based microsphere platform designed to deliver drugs in a controlled, localized, and extended-release manner. This technology ensures a stable pharmacokinetic profile, avoiding the peaks and troughs commonly associated with conventional drug delivery systems. By maintaining high drug concentrations in target tissues while minimizing systemic exposure, DiffuSphere™ enhances efficacy and reduces the risk of adverse events.
Applications of DiffuSphere™ extend beyond osteoarthritis and EoE, with potential uses in oncology, infectious diseases, and other inflammatory conditions. The platform's versatility has been demonstrated in preclinical and clinical studies across various anatomical locations, including intra-articular, intra-esophageal, and subcutaneous applications.
Clinical Development and Pipeline
Eupraxia is actively advancing its clinical programs:
- SPRINGBOARD Trial: A Phase 2b study evaluating EP-104IAR for knee osteoarthritis pain, which met its primary endpoint and three of four secondary endpoints. The results were published in The Lancet Rheumatology, highlighting the product's potential to set a new standard of care.
- RESOLVE Trial: A Phase 1b/2a study for EP-104GI in EoE, demonstrating a strong dose-response relationship and significant improvements in patient-reported symptoms and histological outcomes.
In addition to these lead programs, Eupraxia is developing a pipeline of earlier-stage formulations targeting other inflammatory joint indications and oncology, with a focus on improving the safety and efficacy of existing therapies.
Market Significance
Eupraxia operates in a competitive biotechnology landscape, addressing growing markets such as osteoarthritis, which affects over 30 million people in the U.S., and eosinophilic esophagitis, a rapidly increasing condition impacting over 450,000 individuals in the U.S. alone. The company's targeted, long-acting therapies offer a compelling alternative to traditional treatments, with the potential to improve patient outcomes and reduce healthcare costs.
Competitive Advantages
Eupraxia's differentiation lies in its ability to:
- Deliver drugs locally with precision and extended duration, minimizing systemic side effects.
- Address high unmet medical needs with innovative formulations.
- Leverage a versatile platform technology applicable across multiple therapeutic areas.
These strengths position Eupraxia as a key player in the biotechnology sector, with the potential to transform treatment paradigms in its target markets.
Eupraxia Pharmaceuticals announced positive data from its RESOLVE Phase 1b/2a trial of EP-104GI for treating Eosinophilic Esophagitis (EoE), an inflammatory disease causing difficulty swallowing. The trial showed consistent improvements in histological scores and symptom relief as dosage and esophageal coverage increased.
Cohort 6 demonstrated the most significant results to date, with the greatest symptom relief scores at 12 weeks, largest improvements in tissue health scores, and highest reduction in Peak Eosinophil Count. Cohort 5 showed the greatest symptom score reduction at 24 weeks, with continuously improving relief over time.
Notably, a clear dose-response was observed from Cohorts 3 to 6, with no serious adverse events or oral/gastrointestinal candidiasis reported across all six cohorts. The company believes EP-104GI could become a new standard of care for EoE treatment, with Cohort 7 fully enrolled and 12-week data expected in Q2 2025.
Eupraxia Pharmaceuticals (NASDAQ: EPRX) (TSX: EPRX) has appointed Alex Rothwell as its new Chief Financial Officer, replacing retiring CFO Bruce Cousins, who will remain as a consultant for the transition period. Rothwell, who previously served as Eupraxia's CFO from 2018-2021, brings over 25 years of experience in capital markets and investment banking.
Rothwell's background includes leadership roles at Canadian investment banks, including serving as President and Executive Director of Macquarie Capital Markets Canada. Throughout his career, he has helped raise billions in funding through various structures from early-stage investments to IPOs. He holds a Bachelor of Chemical Engineering from McGill University and an MBA from the Ivey School of Business.
The new CFO expressed optimism about Eupraxia's potential, particularly highlighting EP-104GI for Eosinophilic Esophagitis treatment and EP-104IAR for osteoarthritis knee pain.
Eupraxia Pharmaceuticals (NASDAQ/TSX: EPRX) revealed new pharmacokinetic data from its Phase 2a Eosinophilic Esophagitis program, highlighting its DiffuSphere™ technology. The platform demonstrates targeted drug delivery maintaining therapeutic levels for over six months while minimizing systemic exposure. In clinical trials, DiffuSphere™ showed successful delivery of fluticasone propionate in both EoE and osteoarthritis patients. The technology's unique microsphere composition enables precise drug release into target tissues with a stable profile, achieving high local concentrations while minimizing systemic exposure. Clinical data showed steady drug levels of 1.5 pg/ml for six months in EoE patients at 4mg dose, and 10pg/ml at three months with 48mg dose.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) announced its participation in the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting in Washington, D.C., November 14-19, 2024. The company will present a poster (Number 2106) titled 'EP-104IAR Shows Sustained Improvement in Pain for Subjects with Moderate Baseline Pain and BMI Less Than 30 in SPRINGBOARD.' The presentation focuses on their long-acting intra-articular injection of fluticasone propionate for knee osteoarthritis. Philip G. Conaghan will present the findings on November 18, 2024, from 10:30 a.m. to 12:30 p.m. ET. The poster will be available on Eupraxia's website.
Eupraxia Pharmaceuticals (TSX: EPRX) (NASDAQ: EPRX) announced that CEO Dr. James A. Helliwell will present at a Tribe Public Webinar focused on Eosinophilic Esophagitis (EoE), a digestive disorder affecting over 450,000 people in the United States. The presentation, titled 'Eosinophilic Esophagitis: The Emerging Digestive Disorder Frequently Misdiagnosed,' is scheduled for November 15, 2024, at 8:30 am PT / 11:30 am ET.
The event is open to public registration at EPRXNOV1524.TribePublic.com. Participants can submit questions in advance via email or during the event through ZOOM chat. The webinar will be hosted by Tribe Public's Managing Member, John F. Heerdink, Jr.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) announced positive data from the fifth cohort of its RESOLVE Phase 1b/2a trial for EP-104GI in treating Eosinophilic Esophagitis (EoE). Key highlights include: one patient achieving complete histological remission at 12 weeks, consistent improvement in patient-reported outcomes, and the largest average reduction in symptom scores observed in the fourth cohort at 24 weeks. The fifth cohort showed the greatest percentage change in histology scores to date, with clear dose response across Cohorts 3 to 5. No serious adverse events were reported, and Cohort 6 is fully enrolled with data expected in Q1 2025.
Eupraxia Pharmaceuticals (NASDAQ: EPRX) reported Q3 2024 financial results with a net loss of $6.0 million, compared to $4.9 million in Q3 2023. Cash position stood at $8.7 million as of September 30, 2024. The company announced positive clinical data from its RESOLVE Phase 1b/2a trial for EP-104GI in eosinophilic esophagitis treatment and published Phase 2b SPRINGBOARD trial data in The Lancet Rheumatology. Post-quarter, Eupraxia raised C$44.5 million through a private placement, appointed new executives, and expects funding through Q3 2026.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) has completed a non-brokered private placement raising C$44.5 million through the issuance of 8,905,638 Series 1 Preferred shares at C$5.00 per share. The proceeds will fund clinical trials for EP104GI, research programs, and general corporate purposes. The company appointed Joseph Freedman, former Brookfield Asset Management executive, to its board. The Preferred Shares rank senior to common shares, are convertible to common shares on a one-to-one basis, and will earn dividends after three years. The company also terminated its C$12 million convertible debt facility.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) announced its participation at the American College of Gastroenterology Annual Scientific Meeting 2024 in Philadelphia, presenting two significant posters. The first poster (P2209), which received a Presidential Award, focuses on EP-104GI's pharmacokinetics and tolerability in mini-pigs. The second poster (P3911), designated as an 'Abstract of Interest,' presents efficacy and pharmacokinetic results from the RESOLVE Phase 1b/2a study's first four cohorts. Both presentations, scheduled for October 28-29, 2024, showcase the company's work on their extended-release fluticasone formulation for treating Eosinophilic Esophagitis.
Eupraxia Pharmaceuticals Inc. (NASDAQ: EPRX) (TSX: EPRX) announced the publication of its Phase 2b SPRINGBOARD trial data for EP-104IAR in Lancet Rheumatology. The trial evaluated EP-104IAR for knee osteoarthritis treatment. Key findings include:
1. EP-104IAR demonstrated clinically significant and durable pain relief.
2. Minimal changes in glucose and cortisol were observed.
3. Stable fluticasone propionate concentrations in plasma were maintained.
The study involved 318 participants and met its primary endpoint, showing statistically significant improvement over placebo in WOMAC Pain at 12 weeks (p=0.004). Three of four secondary endpoints also showed significant improvement. The results suggest EP-104IAR's potential to become a best-in-class therapy for knee osteoarthritis, which affects over 30 million people in the U.S. alone.
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