Flex Pharma has begun a Phase II clinical trial (COMMEND) of FLX-787 in the US to treat patients suffering from motor neuron disease (MND) with a focus on amyotrophic lateral sclerosis (ALS).
FLX-787 is a co-activator of TRPA1 and TRPV1, and ALS is characterised by painful and debilitating cramps.
The US Food and Drug Administration (FDA) has granted fast-track designation to FLX-787 for the treatment of severe muscle cramps associated with ALS.
Designed to assess 30mg of FLX-787 three times a day, the randomised, controlled, double-blinded, parallel design Phase II trial will be performed over a period of 28 days.
Flex Pharma president and CEO Dr William McVicar said: “The fast-track designation for FLX-787 is a validation by FDA that cramps are a severe, unmet medical need in ALS.
“While physicians treating ALS patients have come to understand how great an impact severe cramping - and the pain that attends it - can have on the lives of ALS patients, the lack of safe and effective and treatments has provided little impetus to focus on the problem.”
The COMMEND trial will include a run-in period to determine a baseline in cramp frequency, and will measure cramp frequency changes as the primary endpoint, along with various secondary endpoints.
Top-line results from the trial are expected to be reported in the middle of next year, with plans to further study FLX-787 in a Phase II clinical trial for treating Charcot-Marie-Tooth (CMT) over the coming months.