Revalesio, a clinical-stage biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead investigational therapy, RNS60, targeting acute ischemic stroke. This designation aims to expedite the development and review of RNS60, a proprietary oxygen-enriched saline designed to protect brain tissue following ischemic injury, addressing a critical gap in stroke treatment. Acute ischemic stroke, a leading cause of long-term disability and the second leading cause of death globally, often results in permanent neurological deficits despite advances in endovascular thrombectomy, which restores blood flow but does not prevent tissue damage post-reperfusion. Currently, no FDA-approved therapies exist to mitigate brain tissue loss during or after reperfusion, underscoring the urgent need for innovative treatments.
RNS60 enhances cellular resilience by supporting mitochondrial activity, modulating inflammation, and protecting at-risk brain tissue. Preclinical studies and the Phase 2 RESCUE trial demonstrated its potential, with treated patients showing reduced brain tissue loss, improved functional outcomes, and shorter hospital stays when administered within 24 hours of stroke onset.
Beyond stroke, RNS60 is being explored for other neurological conditions, such as amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease, due to its cytoprotective and anti-inflammatory properties. Dr. Jordan Dubow, Revalesio’s Chief Medical Officer, highlighted the therapy’s novel approach, which goes beyond restoring blood flow to preserving neurological function. These promising results have paved the way for the upcoming Phase 3 RESTORE trial, which will evaluate RNS60’s safety and efficacy in a broader population eligible for endovascular therapy. The FDA’s Fast Track program facilitates this development through increased FDA interactions, eligibility for Accelerated Approval, Priority Review, and rolling New Drug Application submissions, emphasizing RNS60’s potential to address an unmet medical need.
This designation marks a significant step toward delivering a transformative treatment for stroke patients, potentially reducing the long-term burden of disability and improving quality of life. Revalesio’s ongoing efforts aim to redefine stroke care and address critical challenges in neurological disease management.
