Positive Phase 2 Results for RNS60 in Acute Ischemic Stroke at ISC 2024

Revalesio, a pharmaceutical firm focused on acute and chronic neurological conditions, has reported positive outcomes from its Phase 2 RESCUE study of RNS60 for acute ischemic stroke (AIS). The study, which took place from February 7-9, 2024, at the International Stroke Conference (ISC) in Phoenix, AZ, demonstrated that RNS60 achieved its primary goals of safety and mortality.

RNS60 is a stable saline solution enriched with oxygen and has shown significant benefits in preclinical studies of neurological disorders. The RESCUE trial was a randomized, double-blinded, placebo-controlled study that involved 82 AIS patients eligible for endovascular thrombectomy (EVT). Participants were treated with either a low or high dose of RNS60 or a placebo before and after EVT for 48 hours.

The study's primary endpoints were safety and mortality, while secondary endpoints included disability assessment using the modified Rankin Scale (mRS), MRI-measured stroke size changes at 48 hours, and other stroke scales like the Barthel Index and the National Institute of Health Stroke Scale (NIHSS).

Key findings from the presentation are that the high dose of RNS60 significantly reduced infarct growth by 50% compared to the placebo and showed numerically better results for each functional endpoint. RNS60 also met its primary endpoints with similar rates of serious adverse events and a lower mortality rate.

Bert van den Bergh, Revalesio's Executive Chairman and former President of Neuroscience Products at Eli Lilly, expressed optimism about RNS60's potential to significantly reduce post-stroke disability. He highlighted Revalesio's novel approach to applying physical principles to biological systems for disease treatment.

Dr. David Liebeskind, Director of UCLA Stroke Center, praised the RESCUE trial's design and execution, emphasizing the importance of adjunctive therapies in stroke treatment. He anticipates the progression of RNS60 to a Phase 3 trial.

Greg Archambeau, President of Revalesio, expressed gratitude for the selection of the Phase 2 data for a late-breaking presentation at the prestigious ISC, reflecting the strength of the study's results. He is confident in the company's ability to design and execute a robust Phase 3 study.

The RESCUE trial's details, including the presentation by Jordan Dubow, M.D., Acting CMO of Revalesio, are available on the ISC 2024 website. Revalesio is dedicated to advancing treatments for neurological disorders, with a focus on technologies rooted in physics to enhance cellular function and improve patient quality of life.