Clinical-stage macrophage reprogramming immunotherapy company Enlivex Therapeutics Ltd. (Nasdaq:ENLV) announced on Thursday that it has received authorization from the Danish Medicines Agency to proceed to Phase II of its multi-country Phase I/II trial targeting moderate and severe knee osteoarthritis.

This approval follows a favourable recommendation from the independent Data and Safety Monitoring Board (DSMB) to advance the trial.

The trial consists of two stages: an initial Phase I safety run-in focusing on dose escalation and a subsequent Phase II stage, which is now being initiated. Phase II will employ a double-blind, randomized, placebo-controlled design, aimed at evaluating the efficacy and safety of Allocetra injections.

Primary endpoints will assess joint pain and function compared to placebo at three, six and twelve months post-treatment.