Revalesio Corporation has reported promising new analyses from its Phase 2 RESCUE clinical trial, showing that RNS60 significantly reduced brain tissue loss in acute ischemic stroke patients when administered within 12 hours of symptom onset. The findings, presented at the International Stroke Conference (ISC) 2025 in Los Angeles, demonstrate a 50% reduction in infarct growth compared to placebo.
The trial results revealed that reduced brain tissue loss correlated with meaningful improvements across multiple functional outcome measures, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). These scales are widely recognized standards for evaluating post-stroke recovery and functional ability.
Trial Design and Implementation
The RESCUE study was designed as a multi-center, double-blinded, placebo-controlled, randomized Phase 2 clinical trial. Researchers enrolled 82 acute ischemic stroke patients who were eligible for endovascular thrombectomy (EVT). Participants received one of three treatments: RNS60 at 0.5 mL/kg/h (low dose), RNS60 at 1.0 mL/kg/h (high dose), or placebo. Treatment administration began before EVT completion and continued for 48 hours.
Key Findings and Clinical Impact
The high-dose RNS60 group demonstrated the most significant benefits, with a 50% reduction in infarct growth (nominal p<0.05) compared to placebo. This reduction was observed in imaging conducted approximately 48 hours post-treatment in patients treated within both 12 and 24 hours of last known well status.
Dr. Marc Fisher, Neurologist at Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President, expressed optimism about the results: "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."
Future Implications
The positive results from the RESCUE trial suggest that RNS60 could represent a significant advancement in stroke treatment. Dr. Fisher emphasized the importance of moving forward with larger-scale testing: "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."
The study's primary endpoints focused on safety and mortality, while secondary endpoints evaluated disability using the mRS, changes in stroke size via MRI at 48 hours, and additional standard stroke assessment scales. These comprehensive measurements provide a strong foundation for future research and development of RNS60 as a potential breakthrough therapy for acute ischemic stroke.
