Revalesio Shares New Phase 2 RESCUE Study Analyses for RNS60 in Stroke

"Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, announced new analyses of its completed phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke (AIS) patients, demonstrating a nominally significant lowering of infarct growth, or brain tissue loss, in patients treated in less than 12 hours following the last time a patient was known to be well.

The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient’s recovery, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). These results were presented during an oral presentation at the International Stroke Conference (ISC) 2025 in Los Angeles, California.

Lowering of infarct growth – brain tissue loss – by 50 per cent in patients treated in less than 12 hours following last known well. Lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient’s recovery.

“This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favorable effects on MRI-confirmed ischemic lesion growth that translated into improved clinical outcomes,” said Dr. Marc Fisher, Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President. “These are exciting results that suggest that RNS60 should be evaluated in a large phase 3 clinical trial that will hopefully confirm its benefits and lead to approval as the first therapeutic agent in decades to demonstrate significant efficacy in improving outcomes for acute ischemic stroke patients.”

In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional standard stroke scales (BI and NIHSS).

RNS60 high dose significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo based on imaging performed at approximately 48 hours compared to immediately post EVT both in patients treated within 12 hours and 24 hours of last known well.

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