Company portrait: Enlivex Chief Medical Officer Einat Galamidi, M.D. Photo: Enlivex (cropped). Not a trial participant or treatment image.
Nes-Ziona-based Enlivex said Wednesday that 135 of a planned 182 patients have been randomized and received their first injection in its Phase 2b Allocetra trial.
The study is testing the experimental treatment in adults aged 64 and older with moderate-to-severe, age-related symptomatic primary knee osteoarthritis. Recruitment is continuing at clinical sites in the United States, Denmark and Poland, according to the company’s October 28 update.
Enlivex expects topline six-month data by mid-2027. Wednesday’s announcement reports enrollment progress, not results from the Phase 2b trial or a regulatory approval.
A blinded comparison with placebo
The multicenter study is randomized, double-blind and placebo-controlled. It is designed to compare the safety and efficacy of injections into the knee joint with placebo in the study population.
Its main efficacy measures include changes in pain and function from baseline, compared with placebo, at three and six months after treatment. Other measures include quality of life and functional mobility.
Reaching 135 participants puts randomization above 70% of the planned total. It does not establish whether Allocetra improves symptoms or how its safety compares with placebo; those questions require the study’s outcome data.
Data still to come
Chief Medical Officer Einat Galamidi said the company remains focused on completing the trial on its stated timeline. The mid-2027 data target is an expectation and may change.
Allocetra is an investigational immunotherapy. Enlivex describes its approach as reprogramming macrophages, immune cells involved in inflammation. The ongoing study is intended to test its use in this older knee-osteoarthritis population.
JBizNews Desk | Israel
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