Enlivex Therapeutics’ off-the-shelf cell therapy has shown six-month success in patients with moderate to severe knee osteoarthritis (KOA).
In the Phase I/II trial (NCT06233474), Allocetra, an allogeneic cell therapy, demonstrated a substantial and durable reduction in pain and improvement in function across multiple efficacy endpoints evaluated in the primary age group of 60+, as compared to placebo after six months.
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This clinically meaningful improvement in pain and function was reported as a 27.8 point reduction in the Allocetra treated group versus a 15.5 point drop in the placebo group, corresponding to 80% improvement, as measured on a scale of 0-100.
These findings are consistent with the three-month observations, where there was a 26.8 point reduction compared to a 13.4 point drop in the placebo cohort.
The analysis revealed a robust positive correlation between patients’ age and the magnitude of the clinical effect and its statistical significance.
Allocetra continued to demonstrate a favourable safety profile through the six-month follow-up, consistent with the previously reported three-month data.
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By GlobalDataStudy author Professor Philip Conaghan 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.”
After announcing the three-month data in August, Enlivex said it planned to obtain regulatory approval from the US Food and Drug Administration (FDA) for a Phase IIb trial of Allocetra, which the company plans to start in the first half of 2026.
According to GlobalData, the osteoarthritis market is expected to reach $8.4bn globally in 2031, up from $6.3bn in 2021.
GlobalData is the parent company of Clinical Trials Arena.
KOA is a painful joint condition that has a global prevalence of more than 300 million as of 2023, according to the World Health Organization (WHO).
There is currently a strong unmet need for patients with KOA. Other than surgery, options include the use of steroids and non-steroidal anti-inflammatory drugs (NSAIDs) such as naproxen and ibuprofen.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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