Canadian-based biotechnology company NoNO has begun the Phase III clinical trial (ESCAPE-NA-1) of NA-1 for the treatment of patients with acute ischemic stroke (AIS).
A part of the class of PSD-95 inhibitors, NA-1 is being developed to disrupt pro-death signalling pathways that involve postsynaptic density-95 (PSD-95) protein.
The multicentre, randomised, double-blinded, placebo-controlled, parallel group, single-dose Phase III trial will evaluate the efficacy and safety of the intravenous NA-1 for reducing functional disability in AIS patients undergoing endovascular thrombectomy.
ESCAPE-NA-1 study is being conducted in collaboration with the University of Calgary Stroke Unit.
NoNO president and chief executive officer Michael Tymianski said: "For the first time, neuroprotection will be evaluated in a clinical setting of ischemia-reperfusion, in which neuroprotection has the largest treatment effect.
"ESCAPE-NA-1 addresses the deficiencies of past neuroprotection trials as it is the first study to have a design grounded in and consistent with the preclinical science, to minimise subject heterogeneity, to ensure that the treatment effect size is maximised, and to enrol subjects in the correct therapeutic window."
The Phase III trial is based on the positive results from a clinical trial ESCAPE conducted by the University of Calgary.
NA-1 has reportedly demonstrated positive outcomes in Phase I and II clinical trials conducted in the US and Canada.
It is being further evaluated in another Phase III FRONTIER trial.
NoNO focuses on developing therapeutic agents that inhibit protein-protein interactions in cellular signals, to treat diseases associated with the nervous system, stroke, traumatic brain injury and neuropathic pain.