TACOMA, Wash. – Revalesio, a clinical-stage pharmaceutical company developing treatments for neurological diseases, presented the design of its recently launched RESCUE Phase 2 clinical trial evaluating RNS60 as a treatment for large vessel occlusion acute ischemic stroke (AIS), as well as new preclinical data supporting the advancement of RNS60 for AIS. The information was shared by Revalesio and collaborators last week during the International Stroke Conference 2022.

RNS60 is produced with proprietary technology that uniquely formulates oxygen in saline to address cellular imbalances linked to mitochondrial dysfunction, such as apoptosis and inflammation. The RESCUE Phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial that will enroll up to 100 patients with AIS undergoing endovascular thrombectomy to evaluate the safety and preliminary signs of efficacy of RNS60. The study is led by Rhode Island Hospital’s Comprehensive Stroke Center in Providence, RI, with new sites in the U.S. beginning to participate in 2022. For more information, please visit clinicaltrials.gov.

“We have been encouraged by RNS60’s impact in multiple models of acute stroke, which demonstrate its ability to rescue brain tissue and improve brain function after ischemic stress, with no safety concerns to date,” said Greg Archambeau, President of Revalesio. “There is a significant need for a treatment offering neuroprotection, and we look forward to advancing RNS60 as a treatment for stroke.

“Stroke is the leading cause of death and disability worldwide and is emotionally devastating to our patients and financially devastating to health care systems – both private and public,” said Ryan A. McTaggart M.D., RESCUE’s principal investigator. “While we can now effectively open blocked blood vessels to restore blood flow, patient outcomes remain compromised by delays in care and brain recovery. We hope RNS60 will bridge patients to endovascular thrombectomy and facilitate recovery afterward. Rhode Island Hospital is pleased to have this opportunity to assess RNS60 in patients affected by stroke in an effort to bring forward additional effective and safe neuroprotective therapies for the patients we serve.”

In addition to the design of RESCUE, Revalesio and collaborators presented exciting new preclinical data, highlighted below:

• In research conducted by Dr. Herman Moreno’s group at the State University of New York, treatment with RNS60 after a transient cerebral artery occlusion in mice led to statistically significant:
  – recovery of learning and memory
  – reduction in stroke volume
  – protection and recovery of compromised neuronal tissue
• In research conducted by Dr. DJ Cook’s group at Queens University in Toronto, Canada, findings from non-human primate stroke models showed that RNS60 administered during AIS significantly:
  – reduced stroke volume
  – rescued brain tissue at risk (stroke penumbra)
  – improved functional outcomes

About RNS60

RNS60 is being developed to provide disease modifying and potentially restorative treatments for neurological diseases. It activates intracellular signaling pathways that increase mitochondrial biogenesis and function and thereby reduces neuronal death and inflammation. RNS60 protects neurons and oligodendrocytes and modulates the activity of immune cells to restore homeostasis. RNS60 has been granted Orphan Drug and Fast Track designations for ALS from the U.S. Food and Drug Administration.

About Revalesio

Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for people with neurological diseases through the development of effective and well tolerated medicines. The company’s pioneering nanotechnology addresses fundamental disease mechanisms, such as mitochondrial dysfunction and inflammation, to provide neuroprotection and thereby slow disease progression and improve quality of life. For more information, please visit revalesio.com.

Contact:
Alicia Davis
THRUST Strategic Communications
Alicia@thrustsc.com