Enlivex secures Danish CTA approval for its Phase 2b Allocetra™ knee osteoarthritis trial, advancing a global study across the U.S., Denmark, and Poland.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Enlivex Ltd. has received Clinical Trial Application (CTA) approval from the Danish Medicines Agency, advancing its Phase 2b program for Allocetra™, a placenta-derived macrophage cell therapy for moderate-to-severe knee osteoarthritis.
The approval follows recent clearance from the U.S. FDA and enables a global, multicenter, randomized, double-blind, placebo-controlled trial across the United States, Denmark, and Poland. The study is expected to enroll approximately 150 patients, with recruitment set to begin in Q2 2026.
The trial will evaluate the safety and efficacy of intra-articular Allocetra™ injections. Primary endpoints focus on changes in pain and physical function compared with placebo at 3 and 6 months. Secondary endpoints include quality of life and functional mobility. The study is powered to detect clinically meaningful differences between treatment and control groups.
CEO Oren Hershkovitz described the Danish approval as a key step in executing the company’s global strategy, noting that a unified multinational program should help generate more robust and consistent clinical data. Allocetra™ is designed to modulate immune responses and address the inflammatory processes underlying osteoarthritis.
Knee osteoarthritis affects more than 32 million adults in the United States and is projected to reach 78 million by 2040. Prevalence increases with age, affecting roughly 30% of individuals by age 60 and up to 50% of those over 65. Despite its scale, no disease-modifying osteoarthritis drugs (DMOADs) are currently approved, with existing treatments limited to symptom management such as pain relief, corticosteroid injections, or surgery.
With regulatory clearances in place, Enlivex plans to initiate enrollment promptly, aiming to demonstrate Allocetra™’s potential to deliver sustained pain relief, improved joint function, and better overall quality of life supporting future registrational development.
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About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication .