, /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company established to advance drugs for complex diseases, today announced that it has received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for vorinostat (RVL-001) as a treatment for Rett Syndrome. Unravel's proprietary BioNAVTM drug discovery platform identified RVL-001 as a promising therapeutic for Rett Syndrome.
Over the past 18 months, Unravel has moved efficiently and rapidly towards clinical testing of RVL-001 in Rett patients. Last year, Unravel announced that it had received positive pre-IND meeting feedback from the FDA for its proposed proof of concept Rett study. In March of this year, Unravel announced the initiation of RVL-001 clinical trial material manufacturing for use in upcoming Rett syndrome clinical trials in the US and .
And last month, Unravel announced its collaboration with on a landmark multicenter US clinical study that will evaluate RVL-001 in Rett syndrome patients. "Receiving an Orphan Drug Designation from the FDA is a validation of our team's commitment to developing new treatment options that can benefit the lives of patients with rare diseases," said , Ph.D.
, Unravel Co-Founder and CEO. "Today's milestone, along with our recently announced Rett clinical trial collaboration with and our upcoming POC Rett study in , illustrates the paradigm-shifting speed by which Unravel can rapidly prototype drugs and evaluate their effi.
