FDA Grants Revalesio Fast Track Status for Als Investigational Drug RNS60
Revalesio announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track status for its investigational drug RNS60 as a treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Fast Track and other expedited review programs of the FDA were designed to speed up drug development for life threatening illnesses.
“Receiving Fast Track designation is an important milestone on the path of developing RNS60 as a treatment for patients suffering from ALS,” said Greg Archambeau, President of Revalesio. “This designation provides increased opportunities to interact with FDA for advice on critical aspects of drug development, such as clinical trial design, and can lead to priority review and accelerated approval.”
Preclinical research has shown that RNS60 protects neurons and other supporting cells in the brain and spinal cord by enhancing mitochondrial biogenesis and ATP production. In a recently completed open label clinical study at Massachusetts General Hospital (MGH), RNS60-treated ALS patients experienced a much slower than expected decline of vital capacity compared to historical controls. Vital capacity is a measure of lung function that is linked to ALS disease progression and mortality. The results of the RNS60 study were published in the journal Muscle & Nerve.
“In people with ALS, vital capacity usually drops by about 3 percentage points every month”, said Archambeau. “In contrast, we saw roughly the same drop over 5 months of treatment in the study at MGH.”
At present, a Phase II study (NCT03456882) of RNS60 has enrolled 76 of 142 ALS patients. “We are hopeful that this placebo controlled study will confirm the vital capacity result we saw in the MGH study,” said Archambeau. “If reproducible, this effect would be significant for the development of RNS60 as a treatment of ALS.”
Revalesio will be available for discussions at the J.P. Morgan Healthcare Conference, January 7 through 10 and can be reached directly, or through Torreya, which has been retained to facilitate business development activities.
About Revalesio Corporation
Revalesio is a pioneering clinical stage biomedical company dedicated to improving the lives of patients with neurodegenerative diseases through developing safe and effective new treatments. Founded in 2007 and based in Tacoma, Washington, Revalesio has partnered with global leaders in biomedical research to develop RNS60. For more information, visit revalesio.com.
Amyotrophic Lateral Sclerosis (ALS) is a fatal degenerative disorder of large motor neurons of the cerebral cortex, brain stem, and spinal cord that leads to progressive paralysis. ALS affects approximately 20,000 patients in the United States. Currently, there is no cure for ALS, and no available treatment to halt, reverse, or prevent the progression of the disease.