Enlivex Therapeutics CEO issues letter to shareholders on Allocetra results

Enlivex Therapeutics (ENLV) issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline results for Allocetra in knee osteoarthritis, KOA, and detailing the next steps planned for its clinical development roadmap. “We believe that these three-month results represent a key positive milestone for Enlivex. After a careful analysis of the data and discussions with multiple physicians and experts who are among the world-leaders in the area of KOA, we believe that Allocetra has the potential to become a leading therapy of choice for the tens of millions of patients with primary KOA, who currently have few and poor treatment options for this debilitating disease… I would like to reiterate some of the key 3-month findings of the study. In addition to assessing the overall safety and efficacy of Allocetra, the study included assessments aiming to find a high-responder patient population, because the term “osteoarthritis” represents a collection of clinical conditions rather than one molecular disease… This objective was met, and in primary idiopathic age-related osteoarthritis patients, a population representing more than half of the total KOA market and 54% of the study population, Allocetra achieved substantial, clinically meaningful and highly statistically significant improvement compared to the control placebo group in pain and function… The treatment effect as represented in the reduction of pain and improvement in function comprises potential Phase III primary endpoints are commonly accepted by the FDA. The following results were observed: 72% reduction in pain vs. placebo and absolute reduction of 49% from baseline in the Allocetra arm, 109% improvement in function vs. placebo and absolute reduction of 50% from baseline in the Allocetra arm”