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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
Enlivex’s first regulatory approval for a late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis following the
About this update from Enlivex Ltd.
[{"type":"text","content":"Enlivex’s first regulatory approval for a late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis following the implementation of its dual-engine value creation model: A clinical-stage quality longevity program powered by a prediction markets treasury strategy. IND clearance follows the positive 3 and 6-month data readout from the Company’s Phase 1/2a multicenter, randomized, double-blind, placebo-controlled clinical trial, which enrolled 134 patients, and demonstrated a robust, durable, clinically meaningful, and statistically significant treatment effect in older patients with knee osteoarthritis. Nes-Ziona, Israel, March 23, 2026 (GLOBE NEWSWIRE) -- Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Allocetra™, the Company’s clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). The FDA’s clearance enables Enlivex to initiate a global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™ in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis, which is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. This is the first regulatory clearance obtained by the Company following the implementation of its dual-engine value creation model, which is centered on the development of a clinical-stage quality longevity program powered by a prediction markets treasury strategy. Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to have received FDA clearance to initiate the Phase 2b clinical trial of Allocetra™ in patients with age-related primary knee osteoarthritis. This milestone represents an important step toward our mission of improving the quality of life of an aging population that is suffering from this debilitating disease with poor availability of treatment options. In our previous clinical study, Allocetra™ demonstrated a robust, durable, and clinically meaningful tre...