Enlivex Reports Positive Phase I/II Trial Data for Allocetra in Knee Osteoarthritis Treatment.

Enlivex Therapeutics announced positive three-month topline data from its Phase I/II trial evaluating Allocetra for knee osteoarthritis. The treatment showed a 24% reduction in knee pain and 26% improvement in knee function compared to placebo. Favorable safety profile with no severe adverse events and limited side effects. The company will host a webinar to discuss the results in detail.

Title: Enlivex Therapeutics Reports Positive Three-Month Topline Data from Phase I/II Trial for Knee Osteoarthritis

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced positive three-month topline data from its Phase I/II trial evaluating Allocetra™ for moderate-to-severe knee osteoarthritis. The trial demonstrated significant improvements across all efficacy endpoints, with the treatment arm showing a 24% reduction in knee pain and 26% improvement in knee function compared to placebo. Notably, in age-related primary osteoarthritis patients, the results were even more impressive, showing a 72% reduction in knee pain and 95% improvement in knee function compared to placebo, achieving statistically significant effects in common Phase III primary endpoints. The treatment demonstrated a favorable safety profile with no severe adverse events, showing only mild to moderate, transient, and treatable side effects. These results represent both clinically meaningful and statistically significant effects in endpoints commonly used in Phase III trials for knee osteoarthritis.

The trial, ENX-CL-05-001, is 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. 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 for the subsequent Phase IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study also assesses efficacy endpoints, including joint pain and function, at 3, 6, and 12 months post-injection.

The company will host a webinar today at 8:00 am Eastern Time to provide in-depth analysis of the results. To join the webinar, please register at: [Webinar Registration Link].

About Allocetra™
Allocetra™ is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions.

References:
[1] https://www.biospace.com/press-releases/enlivex-to-present-3-month-topline-data-from-phase-iia-moderate-severe-knee-osteoarthritis-trial-on-august-18-webinar
[2] https://www.stocktitan.net/news/ENLV/enlivex-announces-positive-topline-data-from-multi-country-ijauoyj1x19x.html