FDA GRANTS VITALITY BIOPHARMA ORPHAN DRUG DESIGNATION FOR VBX-100 PRODRUG
10 AUG 2021 / PRESS RELEASE
CLEVELAND, OHIO - (August 10, 2021) - Vitality Biopharma, Inc. (VBIO) ('Vitality' or the 'Company'), an innovation-driven drug development company dedicated to unlocking the therapeutic powers of cannabinoids, today announced that the U.S. Food and Drug Administration ('FDA') granted Orphan Drug Designation to its glycosylated cannabinoid prodrug VBX-100 for the treatment of pediatric ulcerative colitis.
'The FDA's granting of Orphan Drug Designation for VBX-100, our leading glycosylated cannabinoid for the treatment of inflammatory conditions of the gastrointestinal tract, is a significant milestone for our drug development program,' said Brandon Zipp, Ph.D., Chief Science Officer of Vitality. 'We look forward to accelerating our research efforts to develop safe and effective novel treatments for chronic disorders such as IBS and inflammatory diseases such as IBD, particularly ulcerative colitis in children.'
'We believe that our broad portfolio of over 100 novel glycosylated-cannabinoid compounds, developed using our proprietary enzymatic bioprocessing technologies, possesses significant medicinal potential,' added Michael Cavanaugh, Chief Executive Officer of Vitality. 'The FDA's granting of Orphan Drug Designation to one of our initial novel compounds reaffirms our commitment to the pursuit of additional therapeutic applications for our scores of unique glycosylated cannabinoid molecules.'
The FDA's Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides drug developers with various benefits designed to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, tax credits for qualified clinical trials, and exemption from FDA application fees.
About Vitality Biopharma, Inc.
Headquartered in Los Angeles, California, Vitality Biopharma, Inc. (www.vitality.bio) is a company focused on the advancement of pharmaceuticals and innovative technologies that improve the lives of patients. Vitality seeks to achieve this objective through the development of novel glycosylated cannabinoid prodrugs that are engineered to deliver the therapeutic benefits of cannabinoids but without their unwanted side effects. Vitality has developed over 100 novel cannabinoid compounds, including glycosylated tetrahydrocannabinol (THC) and water soluble glycosylated cannabidiol (CBD) prodrugs.
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Vitality Biopharma, Inc.
Vitality Biopharma Inc. published this content on 10 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 August 2021 13:03:04 UTC.