Revalesio Announces New Analyses from Phase 2 RESCUE Study of RNS60 in Patients with Acute Ischemic Stroke in Oral Presentation at the International Stroke Conference 2025

Lowering of infarct growth – brain tissue loss – by 50% in patients treated in less than 12 hours following last known well

Lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery 

TACOMA, Wash., Feb. 5, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new analyses of its completed Phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke (AIS) patients, demonstrating a nominally significant lowering of infarct growth, or brain tissue loss, in patients treated in less than 12 hours following the last time a patient was known to be well. The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). These results were presented today during an oral presentation at the International Stroke Conference (ISC) 2025 in Los Angeles, CA.

"This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favorable effects on MRI-confirmed ischemic lesion growth that translated into improved clinical outcomes," said Dr. Marc Fisher, Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President.  "These are exciting results that suggest that RNS60 should be evaluated in a large Phase 3 clinical trial that will hopefully confirm its benefits and lead to approval as the first therapeutic agent in decades to demonstrate significant efficacy in improving outcomes for acute ischemic stroke patients."

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 standard stroke scales (BI and NIHSS).

Highlights from the oral presentation include:

• RNS60 high dose significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo based on imaging performed at approximately 48 hours compared to immediately post EVT both in patients treated within 12 hours and 24 hours of last known well.
  
  
• RNS60 high dose was also numerically better than placebo for each prespecified functional endpoint:

• • Modified Rankin Score at Day 90: 72% of subjects on RNS60 high dose were independent (mRS of 0-2) at Day 90 compared to 37% on placebo.
  • Barthel Index at Day 90: 72% of subjects on RNS60 high dose returned to normal activities of daily living (BI³ 95) compared to 37% on placebo.
  • Patient Health Status at Day 90 (as measured by the EQ-5D-5L Index with 1.0 being ideal) was 0.79 for RNS60 subjects and 0.57 for placebo.

• RNS60 was safe and well tolerated

Details of the oral presentation at ISC 2025 are below:

"As the number one cause of disability worldwide, the impact of stroke is staggering, accounting for $721 billion annually to the global healthcare system. Additionally, more than 80% of patients in the U.S. have no treatment options following a stroke, underscoring the significant need for new and effective treatment options," 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. "These highly encouraging results further demonstrate the potential of RNS60 to greatly reduce the likelihood of disability in patients following a stroke, and we plan to advance RNS60 into a Phase 3 clinical trial in order to bring this promising therapy to patients."

Initial topline results of the RESCUE Phase 2 study were presented as a late-breaking oral presentation at ISC 2024, which evaluated patients who were 24 hours from last known well.

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