Business
Enlivex Announces Second Regulatory Approval for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis
· Approval by the Danish Medicines Agency (DKMA) for enrolling patients in Denmark follows the recently announced FDA clearance to initiate the Phase 2b study
About this update from Enlivex Ltd.
[{"type":"text","content":"· Approval by the Danish Medicines Agency (DKMA) for enrolling patients in Denmark follows the recently announced FDA clearance to initiate the Phase 2b study in the United States. Nes-Ziona, Israel, April 21, 2026 (GLOBE NEWSWIRE) -- Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company, today announced that it has received Clinical Trial Application (CTA) approval by the Danish Medicines Agency (DKMA) for the Phase 2b trial of Allocetra™, the Company’s clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). The planned global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial, recently approved by the FDA, has been 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. The clinical trial is designed to enroll patients from clinical centers in the United States, Denmark and Poland. Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “Following the recent FDA clearance, the approval in Denmark marks another key step in executing our global Phase 2b strategy for Allocetra ™. Expanding into Europe reflects our commitment to advancing a unified, multinational development program designed to generate robust clinical data. Osteoarthritis remains a highly prevalent and disabling condition with limited disease-modifying treatment options, and we believe Allocetra™’s unique immunomodulatory mechanism has the potential to address the underlying drivers of inflammation and improve the quality of life for aging patients with knee osteoarthritis. We look forward to initiating patient enrollment and further evaluating Allocetra™’s potential to reduce pain, increase function, and improve quality of life for patients.” The Phase 2b trial has been designed to be statistically powered to evaluate key efficacy endpoints, including change from baseline in pain and physical function compared with placebo, measured at three- and six-months periods following treatment. Additional endpoints include changes in quality-...