By: IPP Bureau
Last updated : November 27, 2025 1:57 pm
Call it a ray of hope for those enduring the pain of knee osteoarthritis -- the most common form of arthritis, affecting over 300 million people worldwide
Enlivex Therapeutics, a clinical-stage company focused on macrophage reprogramming immunotherapies, has announced positive six-month efficacy results from the Phase II stage of its multi-country Phase I/II trial (ENX-CL-05-001) evaluating Allocetra in patients with moderate to severe knee osteoarthritis (OA).
The six-month follow-up, now completed for all participants, reinforces the three-month findings and highlights an age-related responder population in primary OA patients.
As per the key findings at six months, Allocetra continued to demonstrate substantial and durable reductions in pain and improvements in function in patients aged 60 and older, compared to placebo.
The therapy maintained a favorable safety profile throughout the six-month follow-up, consistent with prior observations, as per the company.
Professor Philip Conaghan, consultant rheumatologist and member of Enlivex’s Clinical Advisory Board, said: "The toll of knee osteoarthritis continues to grow with the increasing burden of aging and obesity, and subsequently the need for effective therapies is becoming a major need undertaking."
"With the understanding that inflammatory mediators play a central role in the progression of knee pain and dysfunction, new treatment strategies can be proposed. I am encouraged by the results demonstrated in the study so far and continue to follow the clinical development of Allocetra as an immune modulating agent that could potentially pioneer a new therapeutic approach."
Enlivex CEO Oren Hershkovitz, added: "We believe the six-month results provide strong evidence that Allocetra delivers a durable and clinically meaningful benefit for patients with age-related primary knee osteoarthritis. A single treatment cycle producing at least six months of sustained efficacy represents not only a potentially transformative therapeutic option for patients but also supports a compelling and scalable commercial opportunity for Enlivex."
ENX-CL-05-001 is a two-stage, multi-center Phase I/II trial.