FDA grants RMAT designation to Enlivex's Allocetra for knee OA

Enlivex Ltd. (NASDAQ: ENLV) announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its clinical-stage immunotherapy Allocetra™ for the treatment of age-related symptomatic knee osteoarthritis in patients aged 64 and older.

The FDA based the designation on clinical evidence from a completed Phase I/IIa trial, in which patients with primary age-related knee osteoarthritis treated with Allocetra™ showed statistically significant and clinically meaningful improvements in knee pain and physical function compared with placebo, with efficacy that was durable through at least six months.

RMAT designation makes a therapy potentially eligible for accelerated approval, priority review, and other measures intended to expedite development and approval, along with intensive early FDA engagement.

The FDA has requested a Type B meeting with Enlivex to conduct a multidisciplinary review of the Allocetra™ development program. The company said it intends to schedule the meeting to align on key elements of its Phase IIb trial and pivotal development plans.

Enlivex has initiated a randomized, controlled Phase IIb clinical trial in the United States and the European Union, targeting enrollment of 182 primary knee osteoarthritis patients aged 64 and older. The company said top-line data from the trial is expected by the end of the second quarter of 2027.

Osteoarthritis affects more than 32 million Americans and is projected to affect approximately 78 million Americans by 2040, according to the press release.

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