OXFORD, UK / ACCESSWIRE / January 15, 2020 / IntraBio Inc., a late-stage biopharmaceutical company, is pleased to share that the Extension Phase for the IB1001-201 Clinical Trial has been approved in all European countries where the trial is being conducted.
IB1001-201 is a multinational, clinical trial which investigations N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease Type C (NPC). In Europe, IB1001-201 is being conducted in centers across the United Kingdom, Germany, Spain, and Slovakia.
The approval of the Extension Phases provides patients enrolled in the current trial the opportunity to continue treatment with IB1001 if the principal investigator determines it is in their best interest.
The Extension Phase aims to provide further evidence of the symptomatic benefit of IB1001, and demonstrate the disease modifying, neuroprotective effect of treatment. The long-term benefit of Acetyl Leucine has previously been observed in compassionate use studies and is strongly supported by in vitro and in vivo data.
NPC is a rare, debilitating, inherited lysosomal storage disorder that predominately affects pediatric patients. The disease begins in early childhood and is chronic and progressive in nature, and severely impacts quality of life. The average age of death for NPC patients is approximately 10 years, with half of the patients dying before the age of 12.5 years.
In addition to Clinical Study IB1001-201, IntraBio is running parallel multinational clinical trials involving IB001: IB1001-202 for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease), and IB1001-203 for the treatment Ataxia-Telangiectasia (A-T). An Extension Phase to both studies is also being conducted.
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.