Revalesio Reveals Encouraging Phase 2 Results for RNS60 in Stroke Treatment

Promising Outcomes from Revalesio's RNS60 Clinical Trial

Revalesio Corporation, a pharmaceutical company dedicated to developing innovative treatments for neurological disorders, has made significant strides in the field of acute ischemic stroke management. On May 21, 2025, Revalesio announced impressive results from their Phase 2 RESCUE clinical trial, particularly focusing on the effects of their investigational treatment RNS60 on stroke patients.

Key Findings from the RESCUE Trial

The RESCUE study, which was a multi-center, double-blind, placebo-controlled trial, aimed to evaluate the safety and efficacy of RNS60 in patients suffering from acute ischemic stroke who were eligible for endovascular thrombectomy (EVT).

In this trial, 82 participants were randomized to receive either a high dose (1.0 mL/kg/h) of RNS60, a low dose (0.5 mL/kg/h), or a placebo, starting before the completion of the EVT and continuing for a total of 48 hours. The primary endpoints included safety and mortality, while secondary endpoints assessed disability levels through the modified Rankin Scale (mRS) and the change in stroke size via MRI scans.

The latest analysis focused on a subgroup of patients who received RNS60 within 12 hours of symptom onset. Notably, this subgroup demonstrated a 50% reduction in infarct volume growth—essentially the loss of brain tissue—post-EVT compared to those on a placebo (p<0.05). Furthermore, patients receiving RNS60 were discharged from the hospital approximately 4.8 days sooner (p=0.022).

Additionally, a significant proportion of RNS60 recipients, about 72%, achieved independence as per the modified Rankin Scale by Day 90, contrasting sharply with only 37% of patients in the placebo group.

A Shift in Stroke Recovery Paradigms

Bert van den Bergh, Executive Chairman at Revalesio, highlighted the potential of RNS60 to revolutionize post-stroke care. “These data suggest RNS60 could change the trajectory of stroke recovery,” he remarked. “By preserving brain tissue and reducing the need for extended hospital stays or long-term care, we have the opportunity to fundamentally reshape post-stroke care.”

Greg Archambeau, President of Revalesio and co-inventor of RNS60, stated, “There’s an urgent need for therapies that do more than restore blood flow—these data suggest RNS60 may protect the brain itself.” He emphasized the importance of these findings in advancing RNS60 toward a pivotal Phase 3 trial, aiming to set a new standard of care for stroke treatment.

The Path Ahead

Revalesio’s RNS60 is designed not just as a symptomatic treatment but as a potentially restorative therapeutic option. In preclinical studies, RNS60 has shown the ability to activate intracellular pathways, enhancing mitochondrial function and reducing inflammation, ultimately protecting neuronal health. This therapeutic avenue signifies a departure from traditional stroke treatments that primarily focus on immediate blood flow restoration.

With the encouraging outcomes from the RESCUE trial, Revalesio is poised to further explore the potential of RNS60 in upcoming clinical phases and expand its impact in treating neurological disorders beyond just stroke, including conditions like ALS. The development journey of RNS60 represents a glimmer of hope for many suffering from debilitating neurological conditions, emphasizing Revalesio's commitment to enhancing quality of life through innovative medical solutions.

For further details about RNS60 and Revalesio's ongoing projects, interested individuals can visit revalesio.com or engage with the company on LinkedIn.