TACOMA, WA – Revalesio, a clinical-stage pharmaceutical company focused on developing treatments for neurological diseases, announced that data from multiple clinical studies evaluating the company’s lead drug candidate RNS60, including a Phase 2 trial, are being presented as posters at the ALS/MND International Symposium held December 7-10, 2021.
ALS is a progressive neurodegenerative disease that leads to the degeneration of motor neurons, resulting in paralysis and eventually respiratory failure. RNS60 is produced with proprietary technology to uniquely formulate oxygen in saline to address cellular imbalances linked to mitochondrial dysfunction and inflammation. In multiple preclinical studies, RNS60 has demonstrated disease modifying potential for the treatment of neurological conditions such as ALS, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, stroke and traumatic brain injury.
The placebo-controlled, randomized, double-blind Phase 2 trial was sponsored by the Mario Negri Institute for Pharmacological Research in Milan, Italy and was partially funded through a research grant from the ALS Association. The study enrolled 147 people with ALS who received either RNS60 or placebo over 24 weeks. Designed to primarily explore potential biomarkers for the progression of ALS, the study also assessed the safety and tolerability of RNS60, as well as effects on disease progression measured by endpoints including the ALSFRS-R scale and forced vital capacity (FVC). While there was no impact of RNS60 on the candidate biomarkers or the ALSFRS-R, there was a statistically significant slowing of decline in lung function, as measured by FVC, in patients receiving RNS60. Importantly, RNS60 was well tolerated with an overall safety profile similar to placebo.
“While we urgently work to end ALS, new treatments that help to make ALS livable are critical, and we are encouraged by the potential of RNS60 to do that,” said Neil Thakur, Ph.D., Chief Mission Officer of The ALS Association. “We look forward to working with the company to help advance this potential new treatment to people with ALS as quickly as possible.”
Data from a multi-year Expanded Access Program (EAP) with RNS60 for people with ALS are also being presented at the conference. The EAP is sponsored by and being conducted at the Healey & AMG Center for ALS at Massachusetts General Hospital (MGH). The program is testing the feasibility, safety and tolerability of long-term administration of RNS60 in people with ALS who are not eligible for controlled clinical trials. Since its inception in April 2019, the program has successfully enrolled 52 participants who have been treated for up to 28 months.
In another placebo-controlled study, the mitochondrial mechanism of action of RNS60 was investigated in healthy volunteers at Oregon Health and Science University (OHSU). The study demonstrated a statistically significant increase in mitochondrial oxidative metabolism measured by 31P magnetic resonance spectroscopy.
“Revalesio is committed to improving the lives of people affected by neurodegenerative disorders, and we are pleased and encouraged by these important new data shared by the trial investigators, which provide valuable insight into the potential of RNS60,” said Greg Archambeau, Revalesio’s President. “We are very grateful to the study participants, the caregivers, the investigators and clinical staff, and the ALS Association, who have all contributed to the successful execution of these studies. We look forward to continuing to advance RNS60 in ALS and other neurological conditions.”
RNS60 is being developed to provide disease modifying and potentially restorative treatments for neurological diseases. It activates intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely 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.
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 science and nanotechnology address fundamental disease mechanisms, such as mitochondrial dysfunction and inflammation, to provide neuroprotection and thereby slow disease progression and improve quality of life. Revalesio’s pipeline is led by RNS60, which is currently in Phase 2 clinical trials for the treatment of ALS and acute ischemic stroke. For more information, please visit revalesio.com.
THRUST Strategic Communications