IntraBio Investigational New Drug Application Approved by the FDA for the Treatment of Ataxia-Telangiectasia
Wednesday, March 13, 2019 9:00 AM
OXFORD, UK / ACCESSWIRE / March 13, 2019 / IntraBio Inc., a late-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for Clinical Trial IB1001-203 with its lead compound (IB1001) for the treatment of Ataxia-Telangiectasia (A-T).
The IND approval of IB1001-203 allows IntraBio to proceed with the trial at U.S. clinical sites. In addition to the U.S. centers, IntraBio intends to commence the study in European countries, including the United Kingdom and Germany.
''The FDA's approval of our IND is a significant milestone for both patients and IntraBio,'' said Mallory Factor, Chairman of IntraBio Inc. ''Given the extremely debilitating nature of this disease and the lack of any approved US drug, we are excited to continue moving forward to bring our novel treatment to patients in need.''
A-T, alternatively known as Louis-Barr disease, refers to an autosomal-recessive cerebellar ataxia disorder caused by mutations in the ataxia telangiectasia mutated (ATM) gene. Mutations in the ATM gene cause progressive degeneration to the cerebellum, central nervous system (CNS), and immune system, resulting in cognitive and physical decline and premature death. Like many genetically inherited ataxias, A-T is a disabling, progressive syndrome that severely impairs motor function and quality of life and becomes more disabling over the course of the disease.
In addition to Clinical Study IB1001-203, IntraBio has received approval from the FDA for its IND Application for Clinical Trial IB1001-201 for the treatment of Niemann-Pick disease Type C (NPC), and for Clinical Trial IB1001-202 with IB1001 for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). Enrollment in all three studies is expected to begin in Q2 2019.
IntraBio Inc. is a biopharmaceutical company with a late-stage drug pipeline including novel treatments for common and rare neurodegenerative diseases. IntraBio's platform results from decades of research and investment at premier universities and institutions worldwide. Its clinical programs leverage the expertise in lysosomal function and intracellular calcium signaling of its scientific founders from the University of Oxford and the University of Munich.
IntraBio's management team and consultants have vast commercial experience and a successful track record of drug development in the USA and Europe. Together, IntraBio's team translates innovative scientific research in the fields of lysosomal biology, autophagy, and neurology into novel drugs for a broad spectrum of genetic and neurodegenerative diseases so to significantly improve the lives of patients and their families.
IntraBio Inc. is a US corporation with its principal laboratories and offices in Oxford, United Kingdom.
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SOURCE: IntraBio Inc.