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Troubles du Spectre Autistique :arrêt des essais de phase 3 évaluant le diurétique bumétanide faute d’efficacité (Coline Carré. Le Quotidien du Médecin)

C’est une déception. Les laboratoires Servier et Neurochlore annoncent ce 7 septembre l’arrêt anticipé de leurs deux essais cliniques de phase 3 lancés en 2018 pour évaluer le diurétique bumétanide (Burinex) dans la réduction des troubles du spectre autistique (TSA). « Aucun signe d’efficacité n’a été observé (…). Les résultats de ces études n’ont pas démontré la supériorité de la bumétanide par rapport au placebo », expliquent-ils dans un communiqué commun.

Les deux études randomisées de phase 3 en double aveugle versus placebo devaient évaluer ce diurétique − déjà commercialisé dans le traitement de l’insuffisance cardiaque et de certains œdèmes − dans 14 pays, dont 11 en Europe, dans le cadre d’un Plan d’investigation pédiatrique accordé par l’Agence européenne du médicament (EMA).
422 enfants inclus, de 2 à 17 ans
Le premier essai incluait 211 enfants de 2 à 6 ans, le second, autant, mais âgés de 7 à 17 ans. Ils ont été suivis 6 mois en double aveugle contre placebo, avant de poursuivre sous bumétanide 6 mois supplémentaires. Les critères principaux d’évaluation portaient sur les symptômes clés des TSA : les altérations de la communication et des interactions sociales en présence de comportements stéréotypés et répétitifs.
« Aucun des critères d’efficacité, principal (CARS – Childhood Autism Rating Scale) comme secondaires (SRS – Social Responsiveness Scale -, CGI Scale – Clinical Global Impression Scale -, Vineland), n’a été atteint après 6 mois de traitement, que ce soit chez les enfants âgés de 2 à 6 ans, ou chez les enfants et adolescents âgés de 7 à 17 ans. Les études n’ont révélé aucun problème de sécurité inattendu associé à l’usage de la bumétanide », lit-on.
Un espoir né en 2012
« Les résultats des études cliniques de phase 3 sont une déception majeure », reconnaît le Pr Yehezkel Ben-Ari, président de Neurochlore, société de biotechnologie qu’il a fondée en 2012, avec l’espoir d’améliorer les enfants atteints de TSA en réduisant, grâce à ce diurétique, la concentration intraneuronale en chlore. Directeur émérite de l’Inserm et fondateur de l’Institut de neurobiologie de la Méditerranée, il venait alors de cosigner avec le Dr Éric Lemonnier, pédopsychiatre au CHRU de Brest, une étude prometteuse, portant sur 60 enfants autistes et Asperger, qui montrait une réduction de la sévérité des troubles chez près des trois quarts d’entre eux.
Les années suivantes, Neurochlore a réalisé un essai monocentrique (2A), puis multicentrique (2B) dans 6 centres en France, sur près de 90 enfants, avant de signer en mars 2017 un accord de partenariat avec Servier ouvrant la voie à cet essai de phase 3.
« Les équipes de Neurochlore vont maintenant analyser en détail les résultats des études et potentiellement explorer de nouvelles approches basées sur l’intelligence artificielle qui pourraient permettre d’identifier des sous-populations de personnes atteintes de troubles du spectre autistique pour lesquelles la bumétanide serait active. L’hétérogénéité des TSA rend probablement impossible un traitement unique pour tous les enfants avec TSA », conclut le Pr Yehezkel Ben-Ari.
Une étude chinoise publiée en mars 2020 montrait encore des résultats encourageants, et émettait l’hypothèse d’un rôle clef de la bumétanide sur la réduction du taux du GABA (gamma-aminobutyric acid) dans le cerveau.

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    References:

    JBH News

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