Flex Pharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FLX-787, an investigational treatment for severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS).
FLX-787 is a co-activator of TRPA1 and TRPV1. There is currently no drugs approved to treat severe muscle cramps in this population. Two Phase 2 trials of FLX-787 titled COMMAND and COMMIT are expected to start in the U.S. this quarter in ALS and Charcot-Marie-Tooth (CMT) patient populations, respectively.
An ongoing Phase 2 exploratory study of FLX-787 in 12 ALS patients in Australia will be ended early so the company can focus solely on the new, larger trials in the U.S.
“Data from the Australian study will inform our larger COMMEND clinical trial, particularly regarding baseline cramp frequency and intra-subject variability, which could influence sample size calculation and other aspects of trial conduct for this important U.S. study,” said Thomas Wessel, MD, PhD, and CMO of Flex.
COMMAND and COMMIT will both be randomized, controlled, double-blind, parallel group trials. After a run in period, patients will be randomized to 30mg of FLX-787 administered 3 times a day, or control for 28 days.
The company hopes to have important data from the trials in 2018 which can contribute to a New Drug Application.
For more information visit Flex-pharma.com.