IntraBio is a biopharmaceutical company with a late-stage drug pipeline that includes novel treatments for genetic and neurodegenerative diseases. Their clinical programs leverage the expertise of their scientific founders from the University of Oxford and University of Munich, the preeminent experts and pioneers in discovering and developing small molecule drugs that modulate lysosomal function and intracellular calcium signaling.
With their successful track record of drug development and commercialization, IntraBio’s team translates research in the fields of lysosomal biology, autophagy, and neurology into orphan drugs and treatments that will significantly improve the lives of patients, their caregivers, and families.
Patient and Trial Information
IntraBio Ltd. is pleased to confirm that it has completed recruitment for its Pivotal Trial, Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study (IB1001-301). Read the complete announcement.
IntraBio Ltd. is pleased to share that IB1001-301 has enrolled over 70% of the target number of patients in the second month of recruitment. Recruitment is expected to be completed by December 2022. Read the complete announcement.
IntraBio Ltd. is pleased to confirm the Phase III pivotal trial with N-acetyl-L-leucine (IB1001-301) is active and recruiting in the United States at the Mayo Clinic, MN. Read the complete announcement.
IntraBio Reports Further Detail on Positive Data from IB1001 Multinational Clinical Trial for the Treatment of Niemann-Pick disease Type C. Click here for complete announcement.
IntraBio Reports Positive Data from IB1001 Multinational Clinical Trial for the Treatment of Niemann-Pick disease Type C. Click here for complete Announcement.
IntraBio Receives Fast Track Designation from FDA for IB1001 Treatment of NPC. Click here for complete Announcement.
IntraBio Announces Extension Phase for NPC Accepted in the United States. Click here for complete Announcement.
IntraBio Completes NPC Clinical Trial Enrollment. Click here for complete announcement.
IntraBio IB1001-201 Clinical Trial for NPC Reaches 2/3 of their Recruitment Goal. Click here for complete announcement.
IntraBio Clinical Trial IB1001-201 Open for US Recruitment at Mayo Clinic. Click here for complete announcement.
IntraBio IB1001 Series Update
IntraBio is developing a number of small-molecule drug candidates that have broad applicability to rare and common neurological disorders, genetic, and inflammatory diseases. Their current lead drug candidate, IB1001, is initially being developed to treat three rare, genetic diseases where there are extremely high unmet medical needs: Niemann-Pick disease type C, GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease), and Ataxia-Telangiectasia (A-T; an inherited Cerebellar Ataxia). Click the link below for additional information.
Click here for IB1000 Series development history.
NNPDF Industry Update Webinar Series featuring IntraBio, Inc. Click here for recording.
IntraBio Clinical Trial Authorization Application Approved by the MHRA for the Treatment of NPC. Click here for complete announcement.
IntraBio Investigational New Drug Application Approved by the FDA for the Treatment of NPC. Click here for complete announcement.
IntraBio Receives Niemann-Pick disease Orphan Drug Designation from the FDA for IB1000 Series. Click here for complete announcement.