Revalesio announced recently that the US Food and Drug Administration (FDA) has granted a fast-track designation to RNS60—the company’s lead investigational therapy—for the treatment of acute ischaemic 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, according to a Revalesio press release.
The release notes that, 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—and no US FDA-approved therapies currently exist to protect the brain during or after reperfusion.
RNS60 is described by Revalesio as an oxygen-supersaturated saline intended to support mitochondria activity, increase cellular resilience, modulate inflammation and protect at-risk brain tissue following ischaemic injury. The company 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 of RNS60 was granted based on the Phase 2 RESCUE trial and a supportive preclinical data package, Revalesio also notes.
“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,” commented Jordan Dubow, the company’s chief medical officer. “We believe RNS60 represents a fundamentally different approach to stroke care, and this designation reinforces the importance of advancing it as quickly as possible.”
