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The Clinical Development Program Studying RG6206 (RO7239361) in Duchenne Will be Discontinued


We are writing to share with you unfortunate news about our clinical development program studying RG6206 (RO7239361), an investigational anti-myostatin adnectin protein, in ambulatory boys with Duchenne Muscular Dystrophy (DMD).

We are disappointed to announce that the clinical development program studying RG6206 (RO7239361) in Duchenne will be discontinued. This concerns both RG6206 studies: the open-label extension study of the Phase Ib/II THUNDERJET study, evaluating the safety and tolerability of RG6206 in ambulatory boys with DMD; and the Phase II/III SPITFIRE study, evaluating the efficacy, safety and tolerability of RG6206 in ambulatory boys with DMD. Our decision to close this program was made based on the results of a pre-planned interim data analysis of the Phase II/III SPITFIRE study, which indicated that RG6206 was highly unlikely to demonstrate clinical benefit as defined by meeting the primary endpoint (change from baseline in the North Star Ambulatory Assessment (NSAA) total score versus placebo).

The Clinical Development Program Studying RG6206 (RO7239361) In Duchenne Will Be Discontinued