More Studies Required
“However, recent observations of oral intolerability at the current dose and formulation, in a subset of patients, in both studies, indicate that more formulation and dose-ranging studies are required, which is challenging for the Company based upon our current resources,” Dr. McVicar added.
In November, Flex Pharma trumpeted positive topline data in a randomized, double-blinded, placebo-controlled, cross-over Australian trial in ALS patients with frequent muscle cramps.
Despite the positive results, the company terminated the Australian study early, saying it needed to focus its limited resources on its U.S. Phase 2b COMMEND trial (NCT03196375), designed to assess the ability of FLX-787 to reduce fasciculations in ALS patients. COMMEND was designed to recruit approximately 120 participants in approximately 30 study centers across the U.S.
COMMEND is one of two active-until-now trials assessing FLX-787 for its ability to reduce fasciculations in ALS patients, according to ClinicalTrials.gov. The other is the Phase I/II study FLX-787-107 (NCT03334786). A third Phase I/II trial for the same drug in the same indication, FLX-787-106 (NCT03338114), was withdrawn by company decision as of January 23.
FLX-787 has been under study in CMT in the Phase II COMMIT trial (NCT03254199), which was designed to recruit approximately 120 participants in 20 study centers across the U.S.
In today’s announcement, the company said it will continue to operate with its shrunken staff during the internal review as it continues assessing FLX-787 for a third indication, dysphagia, and operates its HOTSHOT sports nutrition drink, designed to prevent and treat muscle cramps in endurance athletes.
Flex Pharma also disclosed today that it terminated its CMO, Thomas Wessel, M.D., Ph.D., but named him an outside advisor to the company during its strategic review process, effective June 26.
Under a separation agreement with Flex Pharma, the company will pay Dr. Wessel a lump sum payment equal to nine months’ base salary, totaling $257,250, following his termination date, as well as a portion of his monthly COBRA insurance payments over a nine-month period following his termination date. His vested stock options will be exercisable for a period of one year after termination of the Advisor Agreement, which either he or Flex Pharma may terminate upon 30 days’ notice.