Enlivex reaffirms August 18 as target date for Phase II data announcement

Enlivex Therapeutics (ENLV) announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at least three months, the trial’s primary timepoint for measurement of key endpoints. The data are being analyzed and audited, with a target date of August 18, 2025 for the public release of audited topline results for three-month key endpoints, including safety and change from baseline in knee pain and function.The multi-center Phase I/II clinical trial consists of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee, in order to identify the dose and injection regimen or the subsequent Phase IIa stage. This stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol is designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial’s key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment.