Enlivex reports durable 12-month Allocetra data in knee osteoarthritis trial
In patients 64 and older, 79.2% of Allocetra recipients showed a clinically meaningful response at 12 months versus 47.6% on placebo, Enlivex said.
Enlivex Ltd. (Nasdaq: ENLV) said on November 2, 2026 that it had obtained favorable 12-month topline data from the Phase IIa stage of its Phase I/IIa trial, ENX-CL-05-001, evaluating Allocetra in patients with moderate to severe knee osteoarthritis. The randomized, double-blind, placebo-controlled Phase IIa stage was part of the company's multi-country Phase I/IIa trial evaluating Allocetra in patients with moderate to severe knee osteoarthritis.1
In the 64-and-older age group, 79.2% of patients in the Allocetra group achieved a clinically meaningful response at 12 months, compared with 47.6% in the placebo group (p=0.027), a result consistent with the treatment benefit seen at 3 months (80% higher for Allocetra than placebo; p=0.019) and at 6 months (39% higher; p=0.168).1 On WOMAC scores, the pain difference versus placebo was -17.5 points at 3 months (p=0.004), -15.4 points at 6 months (p=0.012), and -12.2 points at 12 months (p=0.113), while the function difference was -19.3 points at 3 months (p=0.0008), -19.5 points at 6 months (p=0.0008), and -13.1 points at 12 months (p=0.067).1 No treatment-related serious adverse events were observed, and adverse events were predominantly transient, mild to moderate local knee reactions, consistent with previously reported data.1
The data will be presented in a poster session at ACR Convergence 2026, running November 6–11, 2026 in Orlando, Florida, with the poster session scheduled for November 8, 2026 from 10:30 AM to 12:30 PM ET.1
This follows the company's October 28, 2026 announcement that 135 of a planned 182 patients had been randomized and administered the first injection of Allocetra in its Phase 2b trial for moderate-to-severe age-related symptomatic primary knee osteoarthritis2, with topline six-month data expected by mid-2027.2 CEO Oren Hershkovitz said the company looks forward to topline data from the Phase IIb trial, enrolling the same population, by the end of the second quarter of 2027.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.