IntraBio Announces Publication of Pivotal Phase III Data with Levacetylleucine for Ataxia-Telangiectasia in The Lancet Neurology
IntraBio Inc. today announced that results from its pivotal Phase III clinical trial evaluating levacetylleucine for the treatment of Ataxia-Telangiectasia (A-T) have been published in The Lancet Neurology.
The peer-reviewed publication, titled “Safety and efficacy of levacetylleucine in ataxia telangiectasia: a phase 3, randomised, double-blind, placebo-controlled crossover trial” reports findings from IntraBio’s pivotal randomized, double-blind placebo-controlled Phase III study of levacetylleucine in patients with A-T, a rare, inherited, progressive neurological disease.
This pivotal study met its primary endpoint, demonstrating statistically significant improvement in neurological symptoms and function compared with placebo, as measured by the Scale for the Assessment and Rating of Ataxia. Treatment with levacetylleucine resulted in a mean change in SARA score of -1.92 compared with -0.14 for placebo, representing a treatment difference of -1.88 points (p<0.001). Levacetylleucine also demonstrated statistically significant improvements on key secondary endpoints, including the International Cooperative Ataxia Rating Scale and Investigator Clinical Global Impression. Levacetylleucine was generally well tolerated, with no drug-related serious adverse events reported.
