Flex Pharma announced that its upcoming Phase 2 COMMIT trial investigating the effects of FLX-787 in patients with cramps associated with Charcot-Marie-Tooth (CMT) disease is approved by the Inherited Neuropathies Consortium (INC).
The INC is composed of academic medical centers, organizations for patient support and research resources focused on advancing research in CMT and provide better care to patients with this condition.
“The Inherited Neuropathies Consortium welcomes this clinical research effort to develop a novel treatment for muscle cramps in patients with CMT neuropathy. Cramping is a very common and often disabling symptom of this disease,” Michael Shy, MD, researcher at the University of Iowa, the INC’s operational center, said in a press release. “We have reviewed the protocol and our organization will reach out to patients with muscle cramps to encourage their participation in this interesting study.”
Flex Pharma plans to start enrolling patients for the COMMIT trial this summer. The study will investigate the effectiveness and safety of FLX-787 (30 mg) administered three times a day for 28 days as a treatment against muscle cramps in CMT patients.
“Muscle cramping can have a significant impact on our patients with CMT neuropathy, and we have compelling data in pediatric and adult populations showing the deterioration in quality of life that many of our patients experience due to frequent cramping,” said Nicholas Johnson, MD, the trial’s lead researcher. “FLX-787 could have meaningful clinical advantages because of its safety profile and the lack of systemic exposure,” he said.
“We are excited that many INC study sites in the U.S. will participate in our Phase 2 trial with FLX-787, which should speed recruitment,” added Flex Pharma’s president of Research & Development, Bill McVicar.
FLX-787 acts by activating two proteins, the TRPA1 and TRPV1 ion channels. Previous studies have demonstrated its capacity to stop muscle cramps induced by electrical stimulation in humans. The drug also reduced cramp frequency and pain in individuals with nocturnal leg cramps.
CMT is a hereditary neurological disease that affects the peripheral motor and sensory nerves motor of the body. Motor nerves control muscle contractions, movement and other activities involving muscles, such as speaking, breathing and swallowing. Symptoms include muscle weakness, abnormal gait and foot deformities.
According to the National Institute of Health, CMT affects about one in 2,500 people in the U.S.