Lancet Rheumatology Publishes Phase 2b Data on EP-104IAR for Knee Osteoarthritis

Eupraxia Pharmaceuticals Inc., a clinical-stage biotechnology company, has announced the publication of their Phase 2b data in Lancet Rheumatology. This publication, a prominent and independent peer-reviewed journal, highlights the promising results of Eupraxia's EP-104IAR for the treatment of knee osteoarthritis. This significant development showcases the potential of EP-104IAR as an advanced therapy for this prevalent condition.

The study, entitled "Efficacy and safety of a novel extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis: a randomized, vehicle-controlled, double-blind, multi-centre, 24-week, Phase 2 trial (SPRINGBOARD)," provides comprehensive data on the clinical benefits and safety profile of EP-104IAR. The trial involved 318 participants who were administered a single intra-articular dose of 25 mg EP-104IAR or a placebo. The study's main goals were to assess the efficacy, safety, and pharmacokinetic properties of EP-104IAR over a 24-week period.

According to Dr. James Helliwell, CEO of Eupraxia, the publication in Lancet Rheumatology elevates the profile of EP-104IAR, underscoring its potential to become a leading treatment for knee osteoarthritis. The data show that EP-104IAR provides significant and durable pain relief without causing major changes in glucose and cortisol levels, maintaining stable fluticasone propionate concentrations in plasma.

Philip Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds and one of the study's authors, highlighted the advanced formulation technology utilized in EP-104IAR. He noted that its improved pharmacokinetic and pharmacodynamic profile offers robust and sustained pain relief, suggesting a significant enhancement in the safety profile for this class of drugs. He expressed optimism about the product candidate's progression into late-stage testing based on the strong data from this Phase 2 study.

The SPRINGBOARD trial demonstrated that EP-104IAR met its primary endpoint with a statistically significant improvement in WOMAC Pain scores at 12 weeks compared to the placebo. Additionally, EP-104IAR showed notable improvements in secondary endpoints such as WOMAC Function, OMERACT-OARSI strict responders, and Area Under the Curve (AUC) for WOMAC Pain. These results highlight a strong and lasting response, providing hope for more effective knee osteoarthritis treatments.

Eupraxia Pharmaceuticals is focused on developing locally delivered, extended-release products utilizing their DiffuSphere™ technology. This proprietary technology is designed for precise drug delivery, targeting specific tissues to reduce adverse events and enhance the efficacy and duration of effect. The company is currently developing advanced treatments for pain and inflammatory gastrointestinal diseases, with potential applications in oncology and infectious disease.

The promising results from the Phase 2b trial of EP-104IAR suggest that it could significantly advance the standard of care for knee osteoarthritis, offering patients a new and more effective treatment option. Eupraxia continues to explore multiple strategies to advance this clinical asset into Phase 3 trials, with the goal of addressing the high unmet medical needs of patients suffering from this debilitating condition.