Revalesio announced that the FDA 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.i 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."
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