US-based biotechnology company Flex Pharma is planning to conduct Phase II clinical programmes to evaluate FLX-787 for treatment of severe neurological diseases of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and peripheral neuropathies such as Charcot-Marie Tooth (CMT).
FLX-787 is a chemically synthesised, single molecule, transient receptor potential (TRP), ion channel activator that has been formulated as an oral tablet.
Under the clinical programmes, the company will conduct proof-of-concept Phase II studies of FLX-787 and two separate exploratory Phase II studies initiated by Flex Pharma, including MS and ALS patients in Australia last year.
The studies will be designed as randomised, controlled, blinded, cross-over trials intended to test the safety and efficacy of FLX-787 in patients who suffer from symptoms such as cramps and spasticity triggered by the disease.
Flex Pharma Scientific co-founder, board member, scientific advisory board co-chair and Nobel laureate Dr Rod MacKinnon said: “We believe that topical Chemical Neuro Stimulation, the process whereby small molecules activate TRP ion channels on sensory nerves in the oral mucosa, triggers a reflex response to inhibit the hyperexcitable motor neurons in the spinal cord and reduce muscle cramps.
“Our approach has a broad range of applications that we believe will ultimately benefit the millions of people that suffer from frequent painful muscle cramps.”
The company is expected to release results from the exploratory MS study by the end of this year.