February 7, 2024

RNS60 met its primary endpoints in RESCUE (safety and mortality)

Clinically relevant improvement with RNS60 on modified Rankin Scale (mRS), Barthel Index, and National Institute of Health Stroke Scale (NIHSS)

Significant lowering of infarct growth by 50% at 48 hours

Revalesio plans to meet with FDA to discuss advancing RNS60 into Phase 3 for Ischemic Stroke

TACOMA, Wash. – Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, announced today topline data from the completed Phase 2 RESCUE clinical trial of RNS60 (NCT04693715) in acute ischemic stroke (AIS) patients during an oral presentation at the Late-Breaking Science session of the International Stroke Conference (ISC) 2024. The conference is being held February 7-9, 2024, in Phoenix, AZ.

RNS60, Revalesio’s lead product candidate, consists of a stable formulation of saline saturated with oxygen through a proprietary process. RNS60 initiates a cascade of biological effects that show significant benefits in preclinical models of acute and chronic neurological disorders, while showcasing a strong safety profile in the 400+ patients who have been administered RNS60 in previous trials. Stroke remains a critical health issue with limited treatment options. This provides a major opportunity for a therapy that shows improvements above the standard of care.

In RESCUE, a double-blinded, placebo-controlled, randomized proof-of-concept trial, Revalesio evaluated the safety and signs of efficacy of RNS60. 82 participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and treated across 5 sites, including the lead site at Rhode Island Hospital’s Comprehensive Stroke Center. The participants 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 (Barthel Index and NIHSS).

Highlights of the late-breaking oral presentation include:

  • RNS60 met its primary endpoints of safety and mortality, with similar rates of SAEs and numerically lower rates of mortality (with no statistical comparison)

  • RNS60 high dose significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo based on imaging done at approximately 48 hours compared to immediately post EVT

  • RNS60 high dose was also numerically better than placebo for each prespecified functional endpoint:
    – mRS at Day 90 (both dichotomized and ordinal analyses)
    – Barthel Index at Day 90
    – NIHSS at each specified timepoint for both absolute value and change from baseline

“RNS60’s topline results are very encouraging and suggest the possibility of RNS60 having a profound impact on reducing disability following a stroke,” says Bert van den Bergh, Revalesio’s Executive Chairman on the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. “Revalesio has been developing and testing novel applications of physics in many different biological systems and has seen activity in a wide range of disease models. The novelty of applying physics to biology compelled me to bring my experience in drug development and commercialization to Revalesio.”

“Stroke is the leading cause of disability and death worldwide and carries an enormous financial burden on the health care ecosystem,” said Dr. David Liebeskind, Director of UCLA Stroke Center. “RESCUE was a well-designed and successfully executed Phase 2 trial and it showcases the potential for adjunctive therapies in stroke. I congratulate the investigators and Revalesio on this early data and look forward to seeing RNS60 in a Phase 3 trial.”

“Having our Phase 2 data selected as a late-breaking oral presentation at one of the most prestigious stroke meetings underscores the strength and quality of our results from RESCUE. With these data, we are confident in our ability to design and run a robust and properly powered Phase 3 study,” said Greg Archambeau, President of Revalesio. “We’d like to thank the clinical teams, as well as the trial participants and their families.”

Details of the late-breaking oral presentation at ISC 2024 are below:

Title: “RESCUE: A Randomized, Blinded, Placebo-controlled, Parallel Group Trial to Determine the Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy”
Primary Investigator: Ryan McTaggart, M.D. Rhode Island Hospital
Session: Late-Breaking Science Oral Abstracts I
Date/Time: Wednesday, February 7, 2024, 2:24 pm
Presenter: Jordan Dubow, M.D., Acting CMO of Revalesio

More information can be found on the ISC 2024 meeting website.

To read the press release, click here: Revalesio Announces Positive Topline Data From Phase 2 Rescue Study of RNS60 In Patients With Acute Ischemic Stroke In Late-Breaking Oral Presentation At ISC 2024

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 pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life.

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Amy Conrad
Juniper Point