NoNO Inc has announced the dosing of the first participant in its Phase 1 clinical trial evaluating NoNO-42—a next-generation neuroprotective drug developed in the company’s PSD-95 inhibitor platform.
NoNO-42 is intended for the treatment of all people experiencing an acute ischaemic stroke. This first-in-human study of the drug will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of NoNO-42 in consecutive cohorts of healthy volunteers.
As per a NoNO press release, NoNO-42 builds on the company’s ground-breaking results with its first-generation PSD-95 inhibitor, nerinetide. In the Phase 3 ESCAPE-NA1 trial, participants who were treated with nerinetide but not with thrombolytics exhibited improved functional independence, reduced stroke mortality, and reduced brain damage on medical imaging.
ESCAPE-NA1 was conducted in stroke in patients who were selected to undergo endovascular mechanical thrombectomy, and provided evidence that such patients may benefit from nerinetide if they are not previously treated with thrombolytics. However, in patients who had already received thrombolytic treatment, this nullified the efficacy of nerinetide. The results from the no-thrombolytic arm are currently under confirmatory testing in the ongoing Phase 3 ESCAPE-NEXT trial.
NoNO-42 was developed to be administered with or without thrombolytic agents. It extends the potential benefits of PSD-95 inhibition to those patients who, in ESCAPE-NA1, were previously treated with thrombolytics and therefore could not benefit from nerinetide.
“The stroke neurology community is extremely excited about the prospects of both nerinetide and NoNO-42, and the academic community is eager to follow-up ESCAPE-NEXT with clinical trials to investigate the efficacy of NoNO-42 in stroke patients,” said global principal investigator Michael Hill (University of Calgary, Calgary, Canada).
NoNO’s PSD-95 inhibitor platform consists of nerinetide, the company’s lead compound for people experiencing an ischaemic stroke; NoNO-42, which is now being evaluated in a Phase 1 study; and NoNO-SC, which is administered subcutaneously to enable the treatment of people experiencing stroke outside of the medical setting by anyone, anywhere.