Feb 15, 2023, 07:00 ET
FDA pre-IND feedback provides a clear path forward to initiate proof-of-concept clinical study in Rett Syndrome patients later this year
BOSTON, Feb. 15, 2023 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), a therapeutics company that leverages a machine-learned model of human health to advance drugs for complex diseases, today announced the successful completion of its Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its RVL001 program in Rett Syndrome.
The FDA provided written responses to Unravel regarding its proposed proof of concept study for RVL001, a promising therapeutic identified by Unravel's proprietary drug prediction platform as potentially beneficial for patients with Rett Syndrome via a previously undrugged target. Unravel believes the written response provides clear guidance for RVL001 IND filing and initiation of its proof-of-concept study in Rett syndrome patients later this year.
"We are pleased to have received positive feedback from FDA on our proposed RVL001 clinical study in Rett Syndrome," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "The successful completion of this key development milestone provides a great validation of Unravel's ability to rapidly move promising therapies into the clinic, much faster than most conventional approaches to drug development."
Rett Syndrome is a rare, X-linked neurological disorder occurring primarily in females, starting in early childhood and leading to debilitating cognitive, motor and autonomic disability. With an incidence of one in every 10,000 to 15,000 female births, Rett Syndrome is an orphan disease with no current FDA-approved treatments. Unravel's proprietary drug discovery platform has identified RVL001 as a promising therapeutic for Rett Syndrome, as well as RVL002, a novel small molecule therapeutic currently being developed.
About Unravel Biosciences
Unravel Biosciences is a personalized therapeutics company that redefines diseases through RNA network analysis to seamlessly bridge target discovery with clinical efficacy of new drugs. Unravel leverages its proprietary BioNAV™ platform combining target and drug discovery, preclinical screening and patient stratification to find treatments for complex diseases impacting the whole body. Unravel's platform discovered RVL001, a proprietary formulation targeting Rett Syndrome that will enter the clinic this year, and RVL002, a new small molecule with applications in CNS and metabolic diseases. www.unravel.bio.
CONTACT: Unravel Biosciences-Richard Novak, PhD, [email protected]
SOURCE Unravel Biosciences, Inc.
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