Enlivex OKd for Phase I/II Trial Evaluating Allocetra in Knee Osteoarthritis

 

• Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients
  

 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health (IMOH) authorized the initiation of a Company-sponsored multi-country, double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.

The Phase I/II multi-center trial is composed of two stages. The first stage is a 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 for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and confirmation by the safety and tolerability independent Data Safety Monitoring Board. On top of evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The primary measurements will be comparisons of joint-pain and joint-function compared to placebo at three months, six months and 12 months.

https://www.globenewswire.com/news-release/2024/01/17/2810641/0/en/Enlivex-Receives-IMOH-Regulatory-Authorization-for-the-Initiation-of-a-Multi-Country-Randomized-Controlled-Phase-I-II-Trial-Evaluating-Allocetra-in-Up-To-160-Patients-with-Moderate.html