Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke

Area of Science:

• Neuroscience
• Cardiovascular System and Hematology
• Pharmacology

Background:

• Acute ischemic stroke with large vessel occlusion (LVO) remains a leading cause of poor outcomes despite reperfusion therapies.
• Adjunctive therapies are crucial to improve outcomes in LVO stroke patients.
• RNS60, a novel oxygen-supersaturated saline solution, exhibits cerebroprotective and immunomodulatory effects, showing promise in preclinical stroke models.

Purpose of the Study:

• To evaluate the safety and efficacy of RNS60 as an adjunctive therapy in patients with LVO stroke undergoing endovascular thrombectomy (ET).
• To assess the impact of RNS60 on infarct volume, clinical outcomes, and quality of life.

Main Methods:

• A randomized, double-blind, placebo-controlled, phase 2 trial (RESCUE) enrolled 82 LVO stroke patients undergoing ET.
• Participants received a 48-hour infusion of RNS60 (0.5 or 1.0 mL/kg/hr) or placebo (1.0 mL/kg/hr).
• Primary end points were serious adverse events and mortality; efficacy end points included modified Rankin Scale, infarct growth, and NIH Stroke Scale.

Main Results:

• RNS60 was safe and well-tolerated, with similar rates of serious adverse events across groups.
• The RNS60 1.0 mL/kg/hr group showed a significant 47% reduction in infarct growth at 48 hours post-ET compared to placebo (P<0.05).
• A trend towards improved functional outcomes, including reduced disability and increased functional independence at 90 days, was observed in the RNS60 1.0 mL/kg/hr group.

Conclusions:

• RNS60 is a safe and well-tolerated adjunctive therapy for LVO stroke patients undergoing ET.
• RNS60, particularly at 1.0 mL/kg/hr, demonstrated a significant reduction in infarct growth, suggesting therapeutic benefit.
• These findings support further investigation of RNS60 in larger, powered clinical trials for acute ischemic stroke treatment.