Posted by Michael Wonder on 26 Jul 2017
FDA grants fast track designation to Flex Pharma’s FLX-787 for the treatment of severe muscle cramps associated with AL
25 July 2017 - Prioritising US phase 2 COMMEND trial; exploratory Australian ALS study to end early.
Flex Pharma today announced that the US FDA has granted fast track designation for the development of FLX-787, the company’s co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with ALS.
There are currently no drugs approved in the US for this condition.
Our COMMEND trial, which is a phase 2 study of primarily ALS patients in the US, has certain advantages to our ongoing ALS study in Australia, including longer run-in and treatment periods, increased dosing, a parallel design, and of course a much larger population from which patients can be recruited. As a result, we have elected to prioritise and focus our efforts on the COMMEND study and will end the exploratory Australian ALS study early, with roughly a dozen patients,” noted Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “The 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 US study.”
