Enlivex Therapeutics Reports Promising Phase I/II Trial Results for Allocetra in Knee Osteoarthritis Treatment

Enlivex Therapeutics reported positive Phase I/II trial results for Allocetra in patients with moderate-to-severe knee osteoarthritis. The trial showed a 72% reduction in knee pain and a 95% improvement in knee function for age-related primary osteoarthritis patients. Allocetra demonstrated a favorable safety profile with no severe adverse events. The results establish Allocetra as a potential breakthrough in managing knee osteoarthritis, addressing the significant unmet medical needs in the growing osteoarthritis market.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced positive three-month topline data from its Phase IIa stage of the ENX-CL-05-001 trial, 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 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 versus placebo [1].

Notably, in the age-related primary osteoarthritis subgroup, 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 [2].

The trial also reported a favorable safety profile with no severe adverse events. Side effects were generally mild to moderate, transient, and treatable, which is crucial for chronic conditions like osteoarthritis where long-term tolerability is essential.

These results establish Allocetra as a potential breakthrough in managing knee osteoarthritis, addressing the significant unmet medical needs in the growing osteoarthritis market. The remarkable efficacy in the age-related subgroup suggests that Allocetra's macrophage reprogramming approach may be particularly effective for this specific patient population, potentially enabling a targeted therapeutic strategy.

The next critical milestones will likely include longer-term data to confirm the durability of the effect and preparations for pivotal Phase III studies.

References:
[1] https://enlivex.com/investors/news-releases/enlivex-announces-positive-topline-data-from-multi-country-randomized-controlled-phase-i-ii-trial-evaluating-allocetra-in-patients-with-moderate-to-severe-knee-osteoarthritis/
[2] https://www.stocktitan.net/news/ENLV/enlivex-announces-positive-topline-data-from-multi-country-ijauoyj1x19x.html