Revalesio Presents Additional Analyses from the Phase 2 RESCUE Clinical Trial for RNS60 in Acute Ischemic Stroke
TACOMA, Wash., May 21, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced data from a post hoc analysis of its completed Phase 2 RESCUE clinical trial, showing that ischemic stroke patients treated with 1.0 mL/kg/h RNS60 plus standard of care endovascular thrombectomy (EVT) within 12 hours of stroke onset showed a larger numerical benefit compared to placebo than the overall group treated within 24 hours. Of note, patients from this subgroup (approximately 75% of the trial participants) experienced a reduction in infarct volume growth (brain tissue loss) post-EVT by more than 50% (nominal p<0.05) and were discharged from the hospital on average 4.8 days sooner (nominal p=0.022) than patients who received EVT and a placebo. These results were presented today during a poster session at the European Stroke Organisation Conference being held in Helsinki, Finland from May 21-23, 2025.
"These data suggest RNS60 could change the trajectory of stroke recovery," said Bert van den Bergh, Revalesio's Executive Chairman of the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. "By preserving brain tissue and reducing the need for long hospital stays or long-term care, we have the opportunity to fundamentally reshape post-stroke care."
Poster Presentation
Title: | Post Hoc Analysis of RESCUE Phase 2 Trial Shows Dose Dependent Improvement in all Prespecified Efficacy Endpoints in Participants <12h Since Symptom Onset |
Date/Time: | Wednesday, May 21, 2025, at 6:55 p.m. GMT (+3) |
Highlights from the poster presentation for the post-hoc subgroup of subjects who were randomized within 12 hours of LKW and received 1.0 mL/kg/h of RNS60:
- Reduction in infarct growth of 50% (p<0.05)
- Discharged 4.8 days sooner from the hospital (p=0.022)
- 72% of subjects were independent compared to 37% on placebo based on dichotomized modified Rankin Scale (0-2) at Day 90 (p=0.13)
- RNS60 was generally safe and well tolerated in the overall intent to treat population
"There's an urgent need for therapies that do more than restore blood flow—these data suggest RNS60 may protect the brain itself," said Greg Archambeau, President of Revalesio and co-inventor of RNS60. "These results support advancing RNS60 into a pivotal Phase 3 trial, with the goal of delivering a meaningful new standard of care."
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
lori.murray@captivate-comms.com
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SOURCE Revalesio Corporation