FDA Allows Revalesio’s Investigational New Drug Application to Study RNS60 in ALS
Revalesio received US Food and Drug Administration (FDA) allowance of an Investigational New Drug (IND) application for Phase II clinical testing of RNS60 in patients with amyotrophic lateral sclerosis (ALS).
RNS60 is currently evaluated in a pilot study in ALS patients at Massachusetts General Hospital. The study was funded by the ALS Therapy Fund. An investigator-sponsored, placebo-controlled, multicenter Phase II study that received grant funding from an ALS association, ALS Finding a Cure, and the Northeast ALS Consortium (NEALS) is expected to start enrolling patients in April of 2017.
The submission of its own IND application paves the way for Revalesio’s next phase of clinical testing of RNS60 as a potential treatment for ALS.