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THERANEXUS ANNOUNCES GERMAN AUTHORITIES APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL

 

Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases and pioneer in the development of drug candidates modulating the interaction between neurons and glial cells, today announces that it has received approval from the German Medicines Agency to launch the opening of the sites for the phase 2 clinical trial of its THN102 drug candidate in Germany for people with Excessive Daytime Sleepiness (EDS) related to Parkinson's disease.


After receiving Investigational New Drug (IND) status from the Food & Drug Administration (FDA) in the United States, Theranexus has now obtained a further European approval for its multicentre clinical study which will be conducted in more than 20 centres in five countries (United States, France, Germany, Hungary, Czech Republic). This study aims to evaluate the clinical benefit of the drug candidate THN102 in 60 patients suffering from Parkinson's disease as well as from EDS.


“We are pleased to announce this approval in Germany which will allow the opening of several centres for the phase 2 Parkinson's study. In the coming weeks, the first patients will be recruited by our network of clinicians under the leadership of Professor Jean-Christophe Corvol of the Pitié Salpêtrière Hospital in Paris, principal investigator of the study,” said Franck Mouthon, CEO of Theranexus.

 

The results of this study are expected in the second quarter of 2019

 

 

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