Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EP-104IAR · 2 trials · 1 indication
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
| Arm | Type | Description |
|---|---|---|
| EP-104IAR 25 mg | EXPERIMENTAL | A single use intra-articular injection containing 25 mg of EP-104IAR |
| Placebo (vehicle) | PLACEBO_COMPARATOR | A single use intra-articular injection containing no active ingredients |
| EP-104IAR | EXPERIMENTAL | 15mg EP-104IAR in 4 mL carrier fluid |
| Vehicle | PLACEBO_COMPARATOR | 4 mL carrier fluid |
| Name | Type | Description |
|---|---|---|
| EP-104IAR 25 mg | DRUG | Single 5 mL intra-articular injection |
| Vehicle | DRUG | Single 5 mL intra-articular injection |
| EP-104IAR | DRUG | Single, ultrasound-guided injection of EP-104IAR into the knee |
Key Inclusion Criteria: * Males or females, aged ≥40 years * Body Mass Index (BMI) ≤ 40.0 kg/m2 * Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months * OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale) * Unsatisfactory pain relief from at least 2...
EP-104IAR is an investigational small molecule being developed for the treatment of osteoarthritis of the knee. It is a long-acting injectable steroid designed to provide relief from knee osteoarthritis symptoms. The drug is currently in clinical development and has not been approved by regulatory authorities.
EP-104IAR is being developed by Eupraxia Pharmaceuticals Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol EPRX. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for knee osteoarthritis.
EP-104IAR is in Phase 2 clinical development. It has completed a Phase 1 safety study and a Phase 2 efficacy and safety study. The drug remains investigational and has not received regulatory approval for any use.
EP-104IAR has completed two clinical trials. The first was a Phase 1 safety study (NCT02609126) with 32 participants in Canada. The second was a Phase 2 efficacy and safety study (NCT04120402) with 318 participants in Czechia, Denmark, and Poland. Both trials were randomized, double-blind, and placebo-controlled.
EP-104IAR is a long-acting injectable steroid designed to deliver sustained release of the medication directly into the knee joint. This approach aims to provide prolonged relief from osteoarthritis symptoms with a single injection, potentially reducing the need for frequent dosing.