Flex Pharma (NASDAQ:FLKS) announced positive topline data for FLX-787 from its placebo-controlled, crossover Australian trial in amyotrophic lateral sclerosis (ALS) patients with frequent muscle cramps.
The study was terminated early to focus the company’s resources on the ongoing U.S. Phase 2b ALS study, known as COMMEND.
“We are encouraged by the consistently positive impact of FLX-787 across multiple efficacy endpoints related to cramping and associated pain, despite the small number of patients completing the study,” Dr. William McVicar, president and CEO, said in a statement.
“These data demonstrate the potential for FLX-787 to benefit ALS patients who suffer from frequent cramping in our ongoing Phase 2b trial, the COMMEND study,” he added.
In patients completing both cross-over periods per protocol:
• FLX-787 showed a median 31% reduction in cramps from baseline versus 0.1% reduction for patients while on placebo control;
• Patients had a median of 4.4 cramp free days versus zero for placebo control;
• Patients evaluated themselves as improved with FLX-787 treatment 50% of the time versus 12.5% with placebo control;
• And clinicians blinded to treatments evaluated 50% of patients as improved with FLX-787 versus 0% for placebo control.
The company expects to report data readouts in multiple sclerosis, ALS, and Charcot-Marie-Tooth over the next year for FLX-787 under fast track designation for ALS-associated cramping.