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 […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-203, “Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in the United States. IB1001-203 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for the treatment of Ataxia-Telangiectasia (A-T). The trial […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-203, “Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in the United Kingdom. IB1001-203 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for the treatment of Ataxia-Telangiectasia (A-T). The […]
IntraBio Ltd. is pleased to share that the IB1001-201 clinical trial has screened two-thirds (2/3) the target number of patients. The study, which investigates N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease Type C (NPC), will enroll a total of approximately 30 patients across all international sites. Since recruitment commenced in September 2019, twenty (20) […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-202, “Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Spain. IB1001-202 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of GM2 Gangliosidosis (Tay-Sachs […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-201, “Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Spain. IB1001-201 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of Niemann-Pick Disease type […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-201, “Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Slovakia at Comenius University in Bratislava. IB1001-201 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-202, “Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Germany. IB1001-202 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of GM2 Gangliosidosis […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-201, “Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Germany. IB1001-201 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of Niemann-Pick Disease type […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-202, “Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in the United Kingdom. IB1001-202 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-201, “Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for US recruitment at the Mayo Clinic. “IntraBio’s IB1001-201 trial is open for recruitment in the United States,” said Mallory Factor, Chairman, IntraBio, “US patients […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-201, “Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in the United Kingdom. IB1001-201 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of Niemann-Pick […]
IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-202, “Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment at all planned United States trial centers. IB1001-202 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for […]
IntraBio Inc. today announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for Clinical Trial IB1001-201 with its lead compound (IB1001) for the treatment of Niemann-Pick disease Type C (NPC). The IND approval of IB1001-201 allows IntraBio to move forward with the trial at U.S. clinical sites. In addition […]
IntraBio Inc. is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for Clinical Trial IB1001-202 involving its lead compound (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). The IND approval of IB1001-202 allows IntraBio to move forward with the trial at U.S. clinical […]
IntraBio Inc today announced that the US Food and Drug Administration has granted Orphan Drug Designation to IB1000s for the treatment of Ataxia-Telangiectasia (A-T). 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 […]
IntraBio is pleased to share an exciting media advisory shared by US Senator Rand Paul’s office regarding a US Senate Congressional Hearing that will be by the Children and Families Subcommittee of the Senate Health, Education, Labor, and Pensions Committee on the 3rd of October at 2:30 PM Eastern Time. The hearing will discuss the […]
IntraBio Inc is pleased to announce that the US Food and Drug Administration has granted a Rare Pediatric Disease Designation for their lead compound series, IB1000s, for the treatment of GM2 Gangliosidoses (Tay-Sachs and Sandhoff diseases). GM2 Gangliosidosis affects an estimated 1:200,000 -320,000 live births and is caused by mutations in the HEXA gene, which disrupt […]
IntraBio Inc is pleased to announce that it has been granted orphan designation by the US Food and Drug Administration, and orphan medicinal drug designation by the European Commission, for its lead drug series, IB1000s, for the treatment of Spinocerebellar Ataxias, of which there are currently over 40 known subtypes. Spinocerebellar Ataxias (SCAs) refers to […]
IntraBio Inc today announced that the US Food and Drug Administration has granted Orphan Drug Designation to Ursodeoxycholic Acid (UDCA) for the treatment of Niemann-Pick disease type C. Niemann-Pick Disease Type C affects 1:100,000 live births, and is most commonly caused by dysfunction of the NPC1 protein leading to the accumulation of lipids in lysosomes, […]
IntraBio Inc is pleased to announce that the US Food and Drug Administration has granted a Rare Pediatric Disease Designation for their lead compound series, IB1000s, for the treatment of Niemann-Pick disease type C. Niemann-Pick Disease Type C (NPC) is a rare, devastating, neurovisceral autosomal-recessive inherited metabolic, lysosomal storage disorder (LSD) that predominantly affects pediatric […]
IntraBio Inc has announced that it has been granted orphan designation by the US Food and Drug Administration for its lead drug series, IB1000s, for therapeutic use in the rare lysosomal storage disorders GM2 Gangliosidoses (Sandhoff and Tay-Sachs Disease). GM2 Gangliosidosis affects an estimated 1:200,000 -320,000 live births and is caused by mutations in the HEXA […]
IntraBio Inc has announced that it has been granted orphan designation by the US Food and Drug Administration for its lead drug series, IB1000s, for therapeutic use in the rare lysosomal storage disorders Niemann-Pick disease type C. Niemann-Pick Disease Type C affects 1:100,000 live births and is most commonly caused by dysfunction of the NPC1 […]
IntraBio Ltd is pleased to announce that it has been granted orphan medicinal drug designation by the European Commission for its lead drug series, IB1000s, for therapeutic use in the rare lysosomal storage disorders GM2 Gangliosidoses (Sandhoff and Tay-Sachs Disease). GM2 Gangliosidosis affects an estimated 1:200,000 -320,000 live births and is caused by mutations in the […]
IntraBio Ltd, a clinical stage biopharmacuetical company developing treatments for rare lysosomal storage disorders and neurodegenerative diseases, today announced that the European Commission has granted Orphan Drug Designation (EU/3/17/1878) to Ursodeoxycholic Acid (UDCA) for the treatment of Niemann-Pick disease (NPC) Type A, B, and C. “We are pleased to receive orphan designation for UDCA, which […]
IntraBio Ltd has announced that it has been granted orphan designation (EU/3/17/1848) by the European Commission on its amino acid analogue-based drug product (IB 1000), for therapeutic use in the rare lysosomal storage disorders Niemann-Pick disease type C and also disease Types A & B. IntraBio, with its collaborators, have completed multiple observational clinical studies […]