Flex Pharma has completed enrolling multiple sclerosis patients in a Phase 2 clinical trial in Australia testing FLX-787’s ability to alleviate muscle stiffness, spasms, and cramps.
The compound has a mechanism of action that Flex believe will generate fewer side effects than other muscle-relaxing medications. The company is also evaluating the drug in people with other neurological diseases, including amyotrophic lateral sclerosis, or ALS.
“Neurologists have very limited therapeutic options for patients suffering from MS spasticity, and the current options are often suboptimal due to their associated side effects,” Dr. Thomas Wessel, Flex Pharma’s chief medical officer, said in a press release.
“Our approach offers a potential important advantage as the drug candidate may reduce cramps or spasticity without the sedating side effects of many current therapies,” Wessel added.
In people with MS, nerve cell damage causes persistent electrical activity in muscles. This leads to spasticity — or muscle stiffness — as well as spasms and cramps. Eighty-four percent of all MS patients have such problems, often in the moderate to severe range, According to the National Institute of Neurological Disorders and Stroke.
FLX-787 prevents electrical muscle activation by activating two types of transient receptor potential ion channels. By allowing positive and negative ions to flow in and out of a cell, such channels guard the cell’s electrical activity.
The company believes the TRPA1 and TRPV1 ion channels are involved in pain and nerve cell inflammation.
The Phase 2 study, which will assess the safety and effectiveness of the drug, is expected to be completed in early 2018.
Recent data has shown that FLX-787 helps alleviate pain and cramping in ALS, said William McVicar, Flex Pharma’s president and CEO. These results suggest that it “may demonstrate a similar effect in this larger exploratory MS study,” he said.
“With data readouts in MS, ALS, and CMT [Charcot-Marie-Tooth] expected over the next year, we are excited to advance the development of FLX-787 in multiple neurological settings to help these patients who have very limited treatment options to address their chronic cramping and spasticity,” he added.