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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...
Top 5 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE3 | Eloralintide and Tirzepatide, Orforglipron, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
EP-104IAR is being developed to treat osteoarthritis of the knee. It is an injectable treatment intended for patients with knee osteoarthritis, a musculoskeletal condition. The program has been studied in adults aged 40 years and older, and the clinical work to date has focused on this single knee osteoarthritis indication.
EP-104IAR is being developed by Eupraxia Pharmaceuticals Inc., which trades under the ticker EPRX. The company is the sponsor behind the clinical program evaluating the asset in knee osteoarthritis, including the Phase 2 trial conducted in Czechia, Denmark, and Poland and an earlier Phase 1 study run in Canada.
EP-104IAR is in Phase 2 development. Two trials have been completed: a Phase 2 study in knee osteoarthritis and a Phase 1 safety study of a long-acting injectable steroid for knee osteoarthritis. No trials are currently listed as active, and the asset is investigational rather than approved.
EP-104IAR has been evaluated in two completed trials. NCT04120402 was a Phase 2 study of efficacy and safety in patients with osteoarthritis of the knee, enrolling 318 participants across Czechia, Denmark, and Poland. NCT02609126 was a Phase 1 safety study of a long-acting injectable steroid for knee osteoarthritis, enrolling 32 participants in Canada.
Both EP-104IAR trials were randomized, double-blind, and placebo-controlled, and together they enrolled 350 participants. The Phase 2 trial NCT04120402 enrolled 318 patients with knee osteoarthritis, and the Phase 1 trial NCT02609126 enrolled 32 patients. Participants were adults aged 40 years and older, and healthy volunteers were not enrolled.