USFDAJul 13, 2026, 08:01 AM
Enlivex Allocetra™ Gets FDA RMAT Designation for Knee OA
AI Summary
Enlivex Ltd. announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra™, its clinical-stage immunotherapy, for age-related symptomatic knee osteoarthritis (OA) in patients aged 64 and older. This designation is based on positive clinical evidence from the completed Phase I/IIa trial and is expected to expedite Allocetra™'s development and approval process, offering benefits like intensive FDA engagement and potential for accelerated approval. The company has initiated a Phase IIb clinical trial and expects top-line data by the end of Q2 2027, with the FDA requesting a Type B meeting to discuss the development program.
Key Highlights
- FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra™.
- Designation is for age-related symptomatic knee osteoarthritis (OA) in patients aged 64 and older.
- RMAT provides intensive FDA engagement, potential for accelerated approval and priority review.
- Based on Phase I/IIa trial data showing significant improvements in knee pain and physical function.
- Company initiated a randomized, controlled Phase IIb clinical trial enrolling 182 patients.
- Top-line data from the Phase IIb trial is expected by the end of Q2 2027.
- FDA requested a Type B meeting to discuss the Allocetra™ development program.
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