CREATE-1 trial of AXS 02 in complex regional pain syndrome is stopped for futility.

THE IDMC conducted an interim analysis of the CREATE-1 trial of AXS 02 in complex regional pain syndrome (CRPS), and of the COAST-1 trial of AXS 02 in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) recommending that the COAST-1 trial be continued to full enrollment, and that the CREATE-1 trial be stopped for futility.

In the CREATE-1 trial, AX 02 treatment resulted in a significant reduction of serum CTx, a marker of bone resorption, as compared to placebo (p<0.0001). Further analysis of the data from the CREATE-1 trial will continue in order to better understand the basis for the outcome of that trial and to inform the ongoing clinical development of AXS 02. The IDMC also reviewed the available safety information in both studies and confirmed that AX -02 was safe and generally well-tolerated. AXS 02 is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain.