Enlivex Therapeutics announces topline data from Phase I/II trial of Allocetra

Enlivex Therapeutics (ENLV) announced six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis. The six-month follow-up has now been completed for all patients. The results re-affirm the three-month data reported previously and substantiate the identification of an age-related primary OA responder population. Summary of the 6-month Topline Data: On August 18, 2025, Enlivex announced the 3-month topline data, reporting that Allocetra demonstrated, in the primary age group, substantial reduction in pain and improvement in function across multiple efficacy endpoints that were evaluated, compared to placebo. The analysis revealed a robust positive correlation between patients’ age and the magnitude of the clinical effect and its statistical significance. At 6 months, Allocetra continued to demonstrate substantial and durable reduction in pain and improvement in function across multiple efficacy endpoints evaluated in the same primary age group, as compared to placebo. These findings are consistent with the 3-month observations, as well as the robust positive correlation between patients’ age and the magnitude of the clinical effect and its statistical significance. Allocetra demonstrated a clinically meaningful improvement in pain and function, a composite endpoint which we expect will be a key endpoint in the follow-up pivotal studies, reaching statistical significance at 3-month at age 60+ and at 6-month at age 61+. Allocetra continued to demonstrate a favorable safety profile through the six-month follow-up, consistent with the previously reported three-month data.