Enlivex Therapeutics reports positive 3-month topline data from its ENX-CL-05-001 trial for AllocetraTM in knee osteoarthritis. The treatment arm showed significant improvements in knee pain and function compared to placebo, particularly in age-related primary osteoarthritis patients. The safety profile was also favorable with no severe adverse events. The company will host a webinar today to discuss the results.
Enlivex Therapeutics (NASDAQ: ENLV) announced today the positive three-month topline data from its ENX-CL-05-001 trial for Allocetra™, a cell therapy designed to reprogram macrophages in patients with moderate-to-severe knee osteoarthritis. The trial demonstrated significant improvements in knee pain and function compared to placebo, particularly in age-related primary osteoarthritis patients.
In the overall modified intention-to-treat (mITT) population, Allocetra™ showed a 24% reduction in knee pain and a 26% improvement in knee function versus placebo. Notably, in the age-related primary osteoarthritis subgroup, the treatment arm achieved a 72% reduction in knee pain and a 95% improvement in knee function, representing clinically meaningful and statistically significant effects in commonly used Phase III primary endpoints for knee osteoarthritis clinical trials [1].
The safety profile of Allocetra™ was favorable, with no severe adverse events reported. Side effects were generally mild to moderate, transient, and treatable, which is crucial for chronic conditions like osteoarthritis where long-term tolerability is essential [1].
The results are particularly notable in the osteoarthritis space, where developing effective treatments has proven challenging. The remarkable efficacy in the age-related subgroup suggests Allocetra™'s macrophage reprogramming approach may be particularly effective for this specific patient population, potentially enabling a targeted therapeutic strategy [1].
Enlivex will host a webinar today at 8:00 a.m. Eastern Time to provide in-depth analysis of the results. The webinar will be hosted by the company and can be accessed by registering at [2].
References:
[1] https://www.stocktitan.net/news/ENLV/enlivex-announces-positive-topline-data-from-multi-country-ijauoyj1x19x.html
[2] https://www.redchip.com/webinar/ENLV/87053863717
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