IntraBio Inc
IntraBio is a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases with high unmet medical needs. The company focuses on developing novel treatments, including IB1001, for conditions such as Niemann-Pick disease Type C, GM2 Gangliosidosis, Lewy Body Dementia, Fronto-Temporal Dementia, and Ataxia-Telangiectasia. IntraBio collaborates extensively with scientists, physicians, and regulatory agencies worldwide to conduct clinical trials and bring effective therapies to patients. The company has received FDA approval for AQNEURSA for Niemann-Pick disease Type C and is engaged in multiple multinational clinical trials for various neurological disorders.
Industries
Nr. of Employees
small (1-50)
IntraBio Inc
201 W 5th Street, Suite 1100, Austin, TX 78701, United States of America
Patents
Acetyl-leucine or a pharmaceutically acceptable salt thereof for improved mobility and cognitive function
US-12329733-B2
View DetailsBetahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase inhibitor, for use in the treatment or prevention of one or more symptoms of vertigo in a subject
US-12121513-B2
View DetailsAcetyl-leucine or a pharmaceutically acceptable salt thereof for improved mobility and cognitive function
US-11998518-B2
View Details
Acetyl-leucine or a pharmaceutically acceptable salt thereof for improved mobility and cognitive function
US-12329733-B2
View DetailsBetahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase inhibitor, for use in the treatment or prevention of one or more symptoms of vertigo in a subject
US-12121513-B2
View DetailsAcetyl-leucine or a pharmaceutically acceptable salt thereof for improved mobility and cognitive function
US-11998518-B2
View DetailsProducts
N-acetyl-L-leucine (modified amino-acid small molecule)
An orally administered modified amino-acid therapeutic developed for symptomatic and potential disease-modifying treatment of rare neurodegenerative lysosomal storage disorders; subject of multiple multinational clinical trials, extension phases and regulatory interactions, and authorized for neurological manifestations of at least one indication.
N-acetyl-L-leucine (modified amino-acid small molecule)
An orally administered modified amino-acid therapeutic developed for symptomatic and potential disease-modifying treatment of rare neurodegenerative lysosomal storage disorders; subject of multiple multinational clinical trials, extension phases and regulatory interactions, and authorized for neurological manifestations of at least one indication.
Services
Provides financial assistance for reasonable out-of-pocket costs, educational resources and dedicated support staff to help eligible patients and caregivers access therapy and navigate insurance and treatment initiation.
Provision of trial information, site contacts and mechanisms for patients and healthcare providers to learn about and enroll in ongoing clinical studies.
Provides financial assistance for reasonable out-of-pocket costs, educational resources and dedicated support staff to help eligible patients and caregivers access therapy and navigate insurance and treatment initiation.
Provision of trial information, site contacts and mechanisms for patients and healthcare providers to learn about and enroll in ongoing clinical studies.
Expertise Areas
- Clinical trial management for rare neurological diseases
- Multinational site network setup and enrollment coordination
- Expanded access and compassionate-use program implementation and data collection
- Preclinical and translational research in lysosomal biology and neuroprotection
Key Technologies
- Oral small-molecule formulation and dosage form development
- In vitro cellular disease models
- In vivo genetic animal disease models
- Preclinical biomarker assays for autophagy and amyloid processing (e.g., LC3-II, APP-CTFs)
News & Updates
IntraBio’s NDA for IB1001 for the treatment of Niemann-Pick disease Type C has been accepted by the FDA.
The pivotal trial results for IB1001 in treating Niemann-Pick Disease Type C have been published in the New England Journal of Medicine.
IntraBio announced positive results from its multinational clinical trial of IB1001, demonstrating significant improvements in symptoms and quality of life.
The trial demonstrated statistically significant and clinically meaningful improvements in symptoms, functioning, and quality of life.
The FDA has accepted the NDA for IB1001 for Niemann-Pick disease Type C, with a PDUFA date set for September 24, 2024.
FDA Approval of AQNEURSA for Niemann-Pick disease Type C
AQNEURSA (levacetylleucine) is the only FDA-approved stand-alone therapy for the treatment of NPC.
IntraBio’s NDA for IB1001 for the treatment of Niemann-Pick disease Type C has been accepted by the FDA.
The pivotal trial results for IB1001 in treating Niemann-Pick Disease Type C have been published in the New England Journal of Medicine.
IntraBio announced positive results from its multinational clinical trial of IB1001, demonstrating significant improvements in symptoms and quality of life.
The trial demonstrated statistically significant and clinically meaningful improvements in symptoms, functioning, and quality of life.
The FDA has accepted the NDA for IB1001 for Niemann-Pick disease Type C, with a PDUFA date set for September 24, 2024.
FDA Approval of AQNEURSA for Niemann-Pick disease Type C
AQNEURSA (levacetylleucine) is the only FDA-approved stand-alone therapy for the treatment of NPC.