Neurotrope receives orphan drug designation for bryostatin-1 by FDA

Release Date: 07-Jan-2017

The FDA has granted Orphan Drug Designation to Neurotrope for bryostatin-1 as a treatment for Fragile X Syndrome. Bryostatin-1 has undergone testing in over 1,500 people establishing a large safety database. Neurotrope is conducting a Phase 2 trial of bryostatin in the treatment of moderate to severe Alzheimer’s disease, as well preclinical studies of bryostatin-1 as a treatment for Fragile X Syndrome and Niemann-Pick Type C disease, two rare genetic diseases for which only symptomatic treatments are currently available. 

Neurotrope, Inc. (OTCQB: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease. Neurotrope is at the forefront of developing a novel therapy to treat and potentially reverse moderate to severe Alzheimer's disease and other neurodegenerative diseases. The Company’s world-class science is a paradigm shifting approach that treats the underlying cause of Alzheimer’s disease.

Orphan Drug Designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

For Orphan Drug Clinical Insight Reports Contact:  neeraj@kuickresearch.com