Servier and Neurochlore announce that no sign of effectiveness was observed in their two phase 3 clinical studies assessing bumetanide versus placebo in the treatment of Autism Spectrum Disorders (ASD) in children and adolescents. As a consequence, Servier and Neurochlore have decided, by mutual agreement, on an early termination of the two clinical studies in progress.
“We had high hopes for bumetanide, which had shown the potential to improve the core symptoms of children and adolescents with autism and the quality of life of their families. We are even more disappointed that today no pharmacological treatment exists to help these young children,” explains Claude Bertrand, Executive Vice President R&D of Servier. “We are pleased to have collaborated with Neurochlore on the development of bumetanide in the core symptoms of autism. This study program was carried out in an extremely rigorous manner, according to the highest standards of quality. We would like to thank the participating families, as well as the investigators and the centers for their involvement in the realization of these clinical studies.”
“The results of the phase 3 clinical studies are a major disappointment,” declares Professor Yehezkel Ben-Ari, President of Neurochlore. “Neurochlore’s teams will now analyze in detail the results of the studies and potentially explore new approaches based on artificial intelligence, which may enable us to identify sub-populations of people suffering from Autism Spectrum Disorders, for whom bumetanide could be effective. The heterogeneity of ASDs probably makes it impossible to offer a sole treatment for all autistic children. We are proud of the work accomplished by the teams who conducted these studies. We would like to thank the children and their families who participated in the trials and for whom the medical need remains significant.”