Accueil   Diary - News   All news THERANEXUS AND BEYOND BATTEN DISEASE FOUNDATION (BBDF) WIN US INVESTIGATIONAL NEW DRUG (IND) APPROVAL TO START CLINICAL DEVELOPMENT OF BBDF 101

THERANEXUS AND BEYOND BATTEN DISEASE FOUNDATION (BBDF) WIN US INVESTIGATIONAL NEW DRUG (IND) APPROVAL TO START CLINICAL DEVELOPMENT OF BBDF 101

 

 

 

Lyon, 9 September 2021 – Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases, and Beyond Batten Disease Foundation (BBDF), announce receipt of Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) to launch a Phase I/II clinical trial of their drug candidate BBDF 101 for juvenile Batten disease1, a rare, fatal, genetic disorder.

 


"With the FDA's IND approval for BBDF 101, we have reached a significant milestone in the drug’s regulatory development plan. This approval will enable us to start clinical development of BBDF 101 in Batten disease, for which there is currently no treatment. Our aim is to be able to provide this treatment to patients suffering from Batten disease as soon as possible," explains Franck Mouthon, CEO of Theranexus.

 

 

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