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Flex Pharma pulls plug on phase 2 ALS trial, plans 60% workforce cut

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Flex Pharma pulls plug on phase 2 ALS trial, plans 60% workforce cut

Flex Pharma Inc. is ending its phase 2 study to treat two degenerative disorders after concerns that patients could not tolerate three daily doses of its experimental pill.

The Boston-based biotech also said it will slash its workforce by 60% in the coming weeks, with most of its restructuring measures announced by June 30.

A subset of patients in the phase 2 trial for FLX-787 — which looked at the therapy for both amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, and another degenerative nerve disorder, Charcot-Marie-Tooth — showed oral intolerability at the current 30-milligram dose and formulation.

The data indicate that more formulation and dose-range studies are needed, President and CEO Bill McVicar said in Flex Pharma's statement, adding that such studies are "challenging for the company based on our current resources."

Flex Pharma had previously reported positive data for the drug in multiple sclerosis and ALS that "demonstrate the clear potential of FLX-787 as a symptomatic therapy to reduce painful cramps and spasms in these patient populations," McVicar said.

The company is now reviewing its options, with Wedbush PacGrow brought on as a strategic financial adviser, with the possibility of both a company sale or merger on the table.

The remaining Flex Pharma staff will focus on FLX-787 in dysphagia, or difficulty swallowing, and operate its consumer business. The layoffs and restructuring will cost between $800,000 and $1 million in one-time fees but realize cost-savings starting in the third quarter of 2018, Flex estimated.