Articles from IntraBio Inc.

IntraBio Inc. announced today that it has completed recruitment for its Phase III Pivotal Trial “IB1001-303”, Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A randomized, placebo-controlled, double-blind, crossover study (NCT06673056).

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 is the only FDA-approved stand-alone therapy indicated for the treatment of NPC.

- First positive clinical trial for GM2 Gangliosidosis - IB1001 demonstrated 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 - Subgroup analysis across the

Multinational clinical trial is the first successful clinical trial for GM2 Gangliosidosis; favourable safety and efficacy data consistent with previously announced IB1001 clinical trial results for NPC OXFORD, UK / ACCESSWIRE / August 19, 2021 / IntraBio Inc today 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