US-based biotechnology company Flex Pharma has commenced the Phase II trial of FLX-787 to treat patients with multiple sclerosis (MS) in Australia.
FLX-787 is the company’s single molecule, chemically synthesised, transient receptor potential (TRP) ion channel activator.
The randomised, controlled, blinded, cross-over trial is intended to assess the safety and efficacy of FLX-787.
MS is an autoimmune disease that causes inflammatory processes, leading to worsening demyelination and cell degeneration over years and resulting in a variety of neurological deficits such as loss of muscle control, sensation and vision.
Damage to motor systems in the brain and spinal cord causes spasticity, which is characterised by hyperactive muscle stretch reflexes caused by lesions.
According to the National Institute of Neurological Disorders and Stroke, about 250,000 and 350,000 people in the US suffer from MS, while approximately 84% of patients suffered MS experience spasticity.
Flex Pharma Scientific co-founder, board member and scientific advisory board co-chair and Nobel laureate Dr Rod MacKinnon said: "We believe that Chemical Neuro Stimulation, the process whereby small molecules activate TRP ion channels topically, leads to sensory stimulation that in turn reduces hyperexcitability in motor neurons.
"We hypothesise that this approach may be generally applicable as a treatment for cramps and spasms in a spectrum of neuromuscular conditions."
According to Flex Pharma clinical research and drug safety vice-president Laura Rosen, the company is intending to initiate three human efficacy studies to administer FLX-787 to patients with MS, ALS and nocturnal leg cramps (NLC).