Flex Pharma Focuses On Phase 2 Clinical Programs In Severe Neurological Diseases

Flex Pharma (FLKS) announced that it is prioritizing its clinical programs in the severe neurological diseases of amytrophic lateral sclerosis, multiple sclerosis and peripheral neuropathies such as Charcot-Marie Tooth.

The Company intends to initiate one or two additional proof-of-concept Phase 2 studies in these indications in the US this year with FLX-787, its transient receptor potential ion channel activator, formulated as an oral disintegrating tablet. In late 2016, the Company began enrolling MS and ALS patients in two separate exploratory Phase 2 studies in Australia.

These randomized, controlled, blinded, cross-over studies are designed to evaluate the safety and efficacy of FLX-787 in patients who suffer from cramps and spasticity as a consequence of their disease. The Company expects to report results from the exploratory MS study by year end 2017. "Flex is well funded through early 2019, and we are committed to executing upon our mission of helping people who suffer from painful and debilitating cramps," stated Christoph Westphal, M.D., Ph.D., Chair and CEO of Flex Pharma.

"By prioritizing our clinical programs to severe neurological diseases ahead of nocturnal leg cramps, we can focus on those patients with the greatest unmet need and accelerate our research efforts for cramps and spasticity," said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. "In 2017, we expect to have multiple Phase 2 studies ongoing with our single agent candidate, FLX-787, with results from our MS study towards the end of the year."

 

Disclosure: None.

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