Enlivex Therapeutics said three-month topline results from the Phase IIa portion of its ENX-CL-05-001 study showed that Allocetra, its off-the-shelf macrophage-reprogramming cell therapy, achieved statistically significant improvements in patients with moderate-to-severe knee osteoarthritis. In the modified intention-to-treat population, Allocetra cut knee pain by 24% and boosted knee function by 26% compared with placebo. An age-related primary osteoarthritis subgroup recorded even stronger outcomes, with pain reduced by 72% and function improved by 95% against placebo. The company reported no severe adverse events, citing mostly mild-to-moderate and transient side effects. The double-blind, randomized, placebo-controlled trial is being conducted across multiple countries and is designed to evaluate pain and function at three, six and 12 months. Nasdaq temporarily halted trading in Enlivex shares ahead of the announcement. Management will discuss the findings during a webcast scheduled for 8 a.m. Eastern Time on Aug. 18.
$ENLV Announces Positive Topline Data From Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis https://t.co/B8ao6AGp1L
Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis $ENLV https://t.co/YrMxilI6A2
$ENLV - Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis - https://t.co/DAMsMIKwJz