Flex Pharma ends development of FLX-787 in ALS, Charcot-Marie-Tooth disease due to oral intolerability

Flex Pharma said Wednesday that it will halt ongoing Phase II studies of the experimental drug FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth disease due to "oral tolerability concerns." Shares in the company, which also disclosed plans to slash its workforce by around 60 percent, slumped over 67 percent on the news.  

The drugmaker noted that in the studies, oral tolerability concerns were seen in a subset of patients being treated with the oral disintegrating tablet formulation at 30 mg, taken three times a day. CEO Bill McVicar said the findings "indicate that more formulation and dose-ranging studies are required, which is challenging for the company based upon our current resources."  

Flex stated that it will continue development of FLX-787, which was previously awarded FDA fast track status for the treatment of severe muscle cramps in patients with ALS, for the treatment of dysphagia. The company indicated that it will examine strategic alternatives, including a potential sale or merger.

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