GlobeNewswire·Mar 23, 2026, 8:00 AM ET

Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis

The U.S. FDA cleared Enlivex's Investigational New Drug (IND) application for Allocetra™ to treat moderate-to-severe age-related primary knee osteoarthritis.
This regulatory milestone enables the initiation of a global Phase 2b multicenter randomized double-blind placebo-controlled clinical trial.
The IND clearance follows positive 3-month & 6-month data from a prior Phase 1/2a trial involving 134 patients that showed robust & durable treatment effects.
The Phase 2b trial will evaluate efficacy endpoints including changes in pain & physical function measured at 3 & 6 months post-treatment.
This approval marks the first regulatory clearance achieved after Enlivex implemented its dual-engine value creation model combining clinical development with a prediction markets treasury strategy.
Enlivex operates a prediction markets treasury built around the RAIN protocol on the Arbitrum network alongside its clinical-stage immunotherapy programs.
Knee osteoarthritis currently affects over 32 million Americans & is projected to impact 78 million by 2040 with no approved disease-modifying therapies available.
CEO Oren Hershkovitz stated the clearance supports a mission to improve quality of life for aging populations suffering from this debilitating condition.