Revalesio to Present Phase 3 Trial Design and Post Hoc Analysis of Phase 2 RESCUE Trial of RNS60 in Acute Ischemic Stroke at the SNIS 22nd Annual Meeting

TACOMA, Wash., July 14, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced that two abstracts featuring its investigational treatment RNS60 in acute ischemic stroke have been accepted for oral presentation at the Society of NeuroInterventional Surgery's (SNIS) 22nd Annual Meeting, taking place in Nashville, TN, July 14-18, 2025.

The presentations will highlight the objectives and design of the company's upcoming Phase 3 clinical trial in acute ischemic stroke (AIS), RESTORE, as well as a new post hoc analysis from its prior Phase 2 RESCUE study of RNS60 in AIS. Both presentations are scheduled for Thursday, July 17, 2025.

"RESTORE: A Phase 3 Study Evaluating Efficacy and Safety of RNS60 as an Adjunct Cytoprotective Treatment in Patients with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy" will be presented from 12:20-12:25 p.m. CT.

"Post Hoc Analysis of RESCUE Shows Improvement in all Prespecified Efficacy Endpoints in Participants Enrolled <12h Since Symptom Onset" will be presented from 12:40-12:45 p.m. CT.

RNS60 is a novel, investigational therapy being evaluated as an adjunct treatment for patients with acute ischemic stroke undergoing endovascular thrombectomy. The therapy targets infarct growth reduction during the acute injury phase, thereby aiming to increase the number of stroke survivors who retain their functional independence.

"What is unique about the design of our Phase 2 RESCUE trial is that we focused on demonstrating RNS60's ability to decrease the growth of the infarct, or brain tissue loss after a stroke, post-endovascular thrombectomy," said Greg Archambeau, President of Revalesio and co-inventor of RNS60. "As we have presented at past conferences, patients treated with high-dose RNS60 in the RESCUE trial had less brain volume loss compared to placebo, and, as one would expect, less brain tissue loss correlated with better patient outcomes."

About the RESCUE Phase 2 Clinical Trial

In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized Phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional endpoints including Barthel Index, NIHSS, and EQ-5D-5L.

About RNS60

RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis.

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 physics, addresses 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
[email protected]

SOURCE Revalesio Corporation