FDA Grants Fast Track Designation for Saline Solution Infusion as Acute Ischemic Stroke Treatment

The Food and Drug Administration (FDA) has granted Fast Track designation to RNS60 (Revalesio, Tacoma, WA), an adjunctive therapy under investigation for the treatment of people with acute ischemic stroke. According to a statement released by Revalesio, RNS60 is designed to fill critical unmet need in stroke care—protecting brain tissue during and after reperfusion, a therapeutic gap not addressed by current standards of care. Revalesio plans to initiate a Phase 3 trial, RESTORE, to further evaluate RNS60 treatment in people with stroke eligible for endovascular therapy.

RNS60 is a proprietary, oxygen-enriched saline solution that functions by supporting mitochondrial activity, reducing inflammation, and enhancing cellular resilience. The drug is administered by infusion and is designed to limit secondary brain damage that can occur even after reperfusion has been achieved. The compound’s mechanism of action is intended to preserve at-risk brain tissue, potentially improving both short- and long-term neurologic outcomes.

The Fast Track designation was supported by results from the Phase 2 RESCUE clinical (NCT04693715) and a preclinical data package. In RESCUE, participants (N=82) with acute ischemic stroke were randomized to receive treatment with RNS60 0.5 mL/kg/hour, 1.0 mL/kg/hour, or placebo.

• The study met its primary end point, with similar rates of serious adverse events (SAEs) for those treated with placebo (28.6%), RNS60 0.5 mL/kg/hour (33.3%), and RNS60 1.0 mgL/kg/hour (25.0%).
• At 48 hours, RNS60 1.0 mL/kg/hour treatment was associated with a 47% reduction in infarct growth compared with placebo (P<.05).
• According to Revalesio, RNS60 treatment within 24 hours of stroke onset was also associated with shorter hospital stays.

"The Fast Track designation underscores the urgent need for new treatments that go beyond restoring blood flow to actually protect brain tissue and preserve neurological function," said Jordan Dubow, MD, Chief Medical Officer of Revalesio. "We believe RNS60 represents a fundamentally different approach to stroke care, and this designation reinforces the importance of advancing it as quickly as possible."