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

Enlivex Therapeutics (ENLV) announced three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra in patients with moderate-to-severe knee osteoarthritis. Oren Hershkovitz, CEO of Enlivex, commented, “We are excited to share the topline three-month data from ENX-CL-05-001. We believe these results provide clear indication that Allocetra has the potential to become a novel, safe and effective treatment for knee osteoarthritis, a growing market with significant unmet medical need.” In the overall modified intention-to-treat population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% improvement in knee function, were observed in the Allocetra treatment arm vs placebo; moreover, 72% reduction in knee pain and 95% improvement in knee function were observed for age-related primary osteoarthritis patients compared with placebo – a substantial, clinically meaningful and statistically significant effect in commonly used Phase III primary endpoints for knee osteoarthritis clinical trials. Favorable safety profile – No severe adverse events; limited, typically mild to moderate, transient, and treatable side effects occurred in most patients treated with Allocetra