Enlivex Randomizes 135 Patients in Phase 2b Knee Arthritis Trial; Topline Data Expected by Mid-2027

Enlivex Ltd. (ENLV) said Wednesday it has randomized 135 of a planned 182 patients in its Phase 2b trial of Allocetra for moderate-to-severe age-related symptomatic primary knee osteoarthritis. Topline six-month data are expected by mid-2027. The global, randomized, double-blind, placebo-controlled study evaluates safety and efficacy of intra-articular knee injections in patients aged 64 and older. Key endpoints measure changes from baseline in pain and function versus placebo at three and six months, with additional endpoints assessing quality of life and functional mobility. Enrollment continues in the U.S., Denmark, and Poland. The trial follows positive three- and six-month Phase 1/2a findings that supported the FDA's Regenerative Medicine Advanced Therapy designation in July 2026. Allocetra is an investigational immunotherapy targeting inflammatory conditions associated with aging. ENLV closed at $2.61, down 3.33%, and rose 2.28% to $2.66 in after-hours trading.