AUSTIN, Texas–(BUSINESS WIRE)–IntraBio Inc. today announced positive topline results from its pivotal Phase III IB1001-303 clinical trial, “Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A Randomized, Placebo-Controlled, Double-Blind, Crossover Study” (NCT06673056) evaluating N-acetyl-L-leucine (levacetylleucine) in pediatric and adult patients with Ataxia-Telangiectasia (A-T). The primary endpoint of the trial evaluated the effect of treatment with levacetylleucine on […]

AUSTIN, Texas–(BUSINESS WIRE)–IntraBio Inc. today announced that the European Commission granted marketing authorization to AQNEURSA® (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick Type C (NPC) disease, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). AQNEURSA® is approved in the European Union for use […]

AUSTIN, TX, September 25, 2024– IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved AQNEURSA (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg. AQNEURSA […]

IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick disease Type C March 26, 2024, 8:00 AM EDT IntraBio Inc today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC). The […]

IntraBio Announces Positive Pivotal Trial Results of IB1001 for the Treatment of Niemann-Pick Disease Type C Phase 3 trial met the primary endpoint and key secondary endpoints showing high statistical significance IB1001 showed a clinically meaningful improvement in symptoms, functioning, quality of life, and cognition in both pediatric and adult patients with NPC IB1001 was […]

IntraBio’s pivotal trial for Niemann-Pick disease type C enrolls 100% of target patients IntraBio plans to “over enroll” trial by over 125% and complete recruitment December 2022 IntraBio’s pivotal trial data readout expected Q2 2023 IntraBio Reaches Target Enrollment for IB1001 NPC Pivotal Clinical Trial OXFORD, UK / November 22, 2022 / IntraBio Inc announced […]

IntraBio’s pivotal trial for Niemann-Pick disease type C has completed recruitment IntraBio’s pivotal trial data readout expected Q2 2023 IntraBio Completes Recruitment for IB1001 NPC Pivotal Clinical Trial OXFORD, UK / December 08, 2022 / IntraBio Inc announced today that it has completed recruitment for its Pivotal Trial, Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type […]

First positive clinical trial for GM2 Gangliosidosis – IB1001 demonstrated a statistically significant and clinically meaningful change in both the primary and secondary endpoints Significant improvement in gait, fine motor skills, speech, cognition, overall functioning, and quality of life reported IB1001 rapidly improved both motor and cognitive symptoms in 6-weeks, consistent with its pharmacological action […]

IntraBio Inc announced positive data from its multinational clinical trial of IB1001 for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease). IB1001 demonstrated a statistically significant and clinically meaningful improvement in symptoms, functioning, and quality of life in both the primary and secondary endpoints for pediatric and adult patients with GM2 Gangliosidosis. The trial […]

We are delighted to announce today that IntraBio’s Co-Founding Scientist Professor Frances Platt has been elected a Fellow of The Royal Society. Professor Platt joins 52 distinguished scientists who were honoured today with their election for their exceptional contributions to science. Professor Platt is a Professor of Biochemistry and Pharmacology and the Head of the […]

IntraBio Reports Further Detail on Positive Data from IB1001 Multinational Clinical Trial for the Treatment of Niemann-Pick disease Type C IB1001 demonstrated a statistically significant and clinically meaningful change in both the primary and secondary endpoints Significant improvement in gait, fine motor skills, speech, cognition, overall functioning, and quality of life reported IB1001 rapidly improved […]

IntraBio Reports Positive Data from IB1001 Multinational Clinical Trial for the Treatment of Niemann-Pick disease Type C Positive results reported from IntraBio’s multinational clinical trial with IB1001 for treatment of Niemann-Pick disease Type C (NPC) Statistically significant and clinically meaningful improvement demonstrated in both the primary and topline secondary endpoints IntraBio is developing IB1001 for […]

OXFORD, UK — IntraBio Inc announced today that their Chief Clinician and Co-Founding Scientist Professor Michael Strupp MD, FRCP, FAAN, FANA, FEAN received the 2020 “Galenus-von-Pergamon” Basic Research Award for his groundbreaking work on a new therapeutic principle for lysosomal storage disorders (LSDs). The Basic Research Galenus-von-Pergamon Award is granted to an individual or team […]

IntraBio Inc. is pleased to share that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead compound (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease). IB1001 (N-acetyl-L-leucine) is currently being investigated for the symptomatic, and disease-modifying, neuroprotective treatment of GM2 in a multinational clinical trial (IB1001-202). […]

IntraBio Inc. is pleased to share that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead compound (IB1001) for the treatment of Niemann-Pick disease Type C (NPC). IB1001 (N-acetyl-L-leucine) is currently being investigated for the symptomatic, and disease-modifying, neuroprotective treatment of NPC in a multinational clinical trial (IB1001-201).  In […]

IntraBio Inc. is pleased to announce that the Extension Phase for the IB1001-202 Clinical Trial has been accepted in the United States, as well as in European countries in which the trial is being conducted, including Germany, Spain, and the UK. IB1001-202 is a multinational, clinical trial that investigates IB1001 (N-acetyl-L-leucine) for the treatment of […]

IntraBio Ltd. is pleased to share that the IB1001-202 clinical trial has screened over two-thirds (2/3) the target number of patients. The study, which investigates N-acetyl-L-leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease), will enroll a total of approximately 30 patients across all international sites. Since recruitment commenced, twenty-three (23) patients […]

IntraBio Inc. is pleased to share results for its lead compound series (IB1000s) for the treatment of dementia, including positive clinical results from compassionate-use studies in patients with Lewy Body Dementia and Fronto-Temporal Dementia, and from pre-clinical studies in Alzheimer’s Disease. Recent compassionate-use studies with IB1000s in patients with Lewy Body Dementia and Fronto-Temporal Dementia […]

IntraBio Inc is pleased to share that it has completed enrollment for its IB1001-201 Clinical Trial.     IB1001-201 investigates N-Acetyl-L-Leucine (IB1001) for both the symptomatic, and long-term, neuroprotective effect of treatment of Niemann-Pick disease Type C (NPC).  Recruitment for IB1001-201 commenced in September 2019 and has since enrolled patients across multinational trial sites in the […]

IntraBio Inc 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 that investigates N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease Type C (NPC). In Europe, IB1001-201 is being conducted in centers […]