Revalesio has announced the peer-reviewed publication of results from its Phase 2 RESCUE clinical trial evaluating RNS60 as an adjunctive treatment in patients with acute ischaemic stroke. Findings from this randomised, proof-of-concept study have been published in the journal Stroke.
RESCUE is described by the company as the first randomised, double-blind, placebo-controlled clinical trial to evaluate RNS60 in patients with large vessel occlusion undergoing endovascular therapy (EVT) procedures.
The trial is assessing RNS60—a proprietary, oxygen-supersaturated saline formulation intended to support mitochondria, increase cellular resilience and modulate inflammation following ischaemic injury—across a total of 82 patients.
RESCUE ultimately met its primary endpoints of similar rates of serious adverse events—33.3%, 25% and 28.6%—and lower mortality rates—6.7%, 8.3% and 14.3%—across groups receiving RNS60 0.5mL/kg/h, RNS60 1mL/kg/h, and placebo, respectively. RNS60 also demonstrated a statistically significant reduction of 47% regarding the secondary endpoint of brain infarct growth at 48 hours in patients treated with the higher dose of RNS60 (1mL/kg/h) compared to placebo (p<0.05).
“Stroke remains the number one cause of disability worldwide, resulting in a substantial global economic burden. The ability to safely deliver a cytoprotective treatment adjunct to EVT would be transformative,” said Marc Fisher (Harvard Medical School, Boston, USA). “The RESCUE trial lays the foundation for a new treatment paradigm in stroke care, where more patients may benefit from effective intervention beyond the narrow window of traditional reperfusion therapies.”
Revalesio details in a press release that it is now preparing to launch the RESTORE study—a Phase 3 clinical trial evaluating RNS60 at 1mL/kg/h in a broader population of stroke patients.
“The publication of these results in a respected peer-reviewed journal underscores the strength of our Phase 2 proof-of-concept data and highlights the urgent need for new treatment options in acute ischaemic stroke,” said Jordan Dubow, chief medical officer at Revalesio. “We are preparing to launch our Phase 3 RESTORE trial to evaluate RNS60 in a larger population and move closer to delivering a meaningful new option for stroke patients.”
