Allocetra - (ENX-CL-05-001)

Nov. 2, 2026: Enlivex Ltd. (NASDAQ: ENLV) reported favorable 12-month topline data from the randomized, double-blind, placebo-controlled Phase IIa stage of its Phase I/IIa trial (ENX-CL-05-001) of Allocetra in moderate to severe knee osteoarthritis.

In patients aged 64+, 79.2% of Allocetra-treated patients achieved a clinically meaningful OMERACT-OARSI response at 12 months versus 47.6% on placebo (p=0.027). The company said this durable benefit was consistent with earlier timepoints: 3 months, 80% higher response versus placebo (p=0.019); 6 months, 39% higher (p=0.168).

For the 64+ subgroup, WOMAC pain improvement versus placebo was -17.5 points at 3 months (p=0.004), -15.4 at 6 months (p=0.012), and -12.2 at 12 months (p=0.113); WOMAC function improvement versus placebo was -19.3 (p=0.0008), -19.5 (p=0.0008), and -13.1 (p=0.067), respectively.

No treatment-related serious adverse events were observed; adverse events were mainly transient, mild to moderate local knee reactions. The Phase IIa stage randomized and treated 134 patients.

Upcoming catalysts: 12-month data will be presented at ACR Convergence 2026 on Nov. 8, 2026; topline data from the ongoing Phase IIb trial are expected by the end of Q2 2027.