Dive Brief:
- After reporting positive data in earlier studies, safety concerns are pushing Flex Pharma to shut down the development of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
- Due to lack of resources, the Boston-based biotech is exploring strategic options including a sale or a merger, and has engaged Wedbush PacGrow as a financial advisor.
- Flex Pharma is cutting 60% of its staff and only retaining a reduced internal team to focus on moving FLX-787 in dysphagia, or difficulty swallowing, while strategic options are explored.
Dive Insight:
FLX-787 is meant to treat cramps, spasms and spasticity associated with severe neurological disorders. The liquid formulation of the drug showed some success earlier this year in reducing the frequency of cramps and spasms in a Phase 2 study of multiple sclerosis patients.
Yet, the company revealed on Wednesday that subsets of patients in two studies — one in ALS and another in CMT — experienced "oral tolerability concerns." The company did not elaborate, but noted that the studies were testing the oral disintegrating formulation instead of the liquid formulation used in the MS study.
Bill McVicar, president and CEO of the company, said in a statement that more dose-ranging and formulation studies are required, but that it would be "challenging for the company based upon our current resources."
Flex Pharma had $23.9 million in cash and equivalents as of March 31. It brought in $179,000 in revenue during the first quarter related to a consumer product called HotShot that it markets.
So it goes in the biotech world; fortunes can change on a dime. Just a month ago, the company was touting the efficacy of FLX-787 and seemed on track after earning a Fast Track Designation from the Food and Drug Administration. But the situation also illustrates just how costly drug development can be and the difficulties for a small biotech to fund development without backing of a big pharma partner.