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Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, announced that the US Food and Drug Administration has granted Fast Track designation to RNS60, its lead investigational therapy, for the treatment of acute ischemic stroke. This designation is intended to accelerate the development and review of RNS60, which could fill a major gap in stroke care by protecting brain tissue even after blood flow is restored with standard procedures and medications.
Stroke is a leading cause of long-term disability and the second leading cause of death worldwide. While advances in endovascular thrombectomy have improved outcomes for some patients, a large percentage continue to experience permanent neurological deficits due to brain tissue damage sustained even after blood flow is restored. No FDA-approved therapies currently exist to protect the brain during or after reperfusion.
RNS60 is an oxygen-supersaturated saline intended to support mitochondria activity, increase cellular resilience, modulate inflammation and protect at-risk brain tissue following ischemic injury. Revalesio is currently preparing to initiate RESTORE, a phase 3 trial that will evaluate the safety and efficacy of RNS60 in a broader population of stroke patients eligible for endovascular therapy. The Fast Track designation was granted based on the phase 2 RESCUE trial and a supportive preclinical data package.
“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 Dr. Jordan Dubow, 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.”
The FDA’s Fast Track programme is designed to facilitate the development and expedite the review of therapies that treat serious or life-threatening conditions and have the potential to address unmet medical needs. Programs granted Fast Track designation benefit from more frequent interactions with the FDA, eligibility for Accelerated Approval and Priority Review, and the option to submit a New Drug Application on a rolling basis.
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.
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 programme for RNS60 is ischemic stroke with additional programmes in ALS and other neurological disorders.
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