Revalesio Announces Publication of RESCUE Phase 2 Trial Results Evaluating RNS60 as an Adjunctive Therapy for Acute Ischemic Stroke in the Journal Stroke

Trial met primary endpoints of similar rates of serious adverse events (SAEs) and fewer deaths observed with RNS60 versus placebo

Statistically significant reduction in infarct growth (brain tissue loss) – a secondary endpoint – in patients treated with RNS60 adjunct to endovascular thrombectomy

Results support advancement of RNS60 to Phase 3

TACOMA, Wash., July 21, 2025 /PRNewswire/ -- Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced the peer-reviewed publication of results from its RESCUE Phase 2 clinical trial evaluating RNS60 as an adjunctive treatment in patients with acute ischemic stroke. The paper, titled "Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke," appears in the journal Stroke.

RESCUE is the first randomized, double-blind, placebo-controlled clinical trial to evaluate RNS60 in patients (n=82) with large vessel occlusion, or blockage in one of the brain's main arteries, undergoing endovascular thrombectomy (EVT), a standard of care procedure to remove blood clots from the brain. RNS60 is a proprietary, oxygen-supersaturated saline formulation intended to support mitochondria, increase cellular resilience and modulate inflammation following ischemic injury. The RESCUE trial met its primary endpoints of similar rates of SAEs (33.3%, 25.0% and 28.6%) and fewer deaths (6.7%, 8.3% and 14.3%) across RNS60 0.5 mL/kg/h, RNS60 1.0 mL/kg/h, and placebo, respectively. RNS60 also demonstrated a statistically significant 47% reduction in infarct growth (brain tissue loss) – a secondary endpoint – at 48 hours in patients treated with RNS60 at 1.0 mL/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, M.D., Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President. "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 is preparing to launch the RESTORE study, a Phase 3 clinical trial evaluating RNS60 at 1.0 mL/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 ischemic stroke," said Jordan Dubow, M.D., 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."

About RNS60
RNS60 is a proprietary, oxygen-enriched saline with demonstrated cytoprotective, anti-inflammatory, and mitochondrial-supportive properties. The treatment is being developed as an adjunctive therapy for acute ischemic stroke and in other neurological conditions, such as ALS and Alzheimer's Disease. The company is preparing to launch a Phase 3 clinical trial of RNS60 in acute ischemic stroke based on promising Phase 2 data showing reduced brain tissue loss, improved functional outcomes, and shorter hospital stays in patients treated within 24 hours of stroke onset.

About Revalesio
Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in fluid physics, modulates fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life.

For more information, please visit revalesio.com and engage with us on LinkedIn.

Media:
Lori Murray
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SOURCE Revalesio Corporation