Enlivex Initiates Phase I/II Trial for Allocetra for Knee Osteoarthritis

Enlivex Initiates Phase I/II Trial for Allocetra for Knee Osteoarthritis

By, Admin 24 April 2024

Enlivex Initiates Dosing of Initial Two Patients in Phase I/II Trial to Evaluate Allocetra™ for Knee Osteoarthritis

Overview

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has commenced dosing for the initial two patients in its Phase I/II trial evaluating AllocetraTM for moderate to severe knee osteoarthritis. This multi-country trial aims to enroll up to 160 patients.

About Trial

The Trial Consists of Two Stages:

  • An initial safety run-in phase and a subsequent randomized, controlled phase. The safety run-in phase, focusing on dose escalation and open-label administration, will determine the appropriate dosage and injection schedule for the randomized phase. 
  • Following the safety run-in, a double-blind, placebo-controlled stage will assess both safety and efficacy, with primary endpoints centered on joint-pain and joint-function compared to placebo at three, six, and twelve months post-treatment.
  • Dr. Einat Galamidi, Vice President of Medical at Enlivex, expressed satisfaction with the trial's progress, highlighting the enrollment and dosing of the initial participants. This phase is crucial in establishing the groundwork for the subsequent randomized stage.

Osteoarthritis

  • Osteoarthritis, affecting millions worldwide, represents a significant unmet medical need, with current treatments primarily focused on symptom management. 
  • AllocetraTM, designed to reprogram macrophages into their normal state, offers a promising therapeutic approach for various diseases, including knee osteoarthritis, where macrophage dysfunction plays a significant role in disease severity.

This milestone marks a step forward in Enlivex's mission to address critical medical needs through innovative immunotherapy approaches.

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