Flex Pharma’s board of directors has named William McVicar, PhD, as the company’s new president and chief executive officer. McVicar will continue supporting the company’s development of new therapies to treat muscle cramps and spasticity associated with serious neurological conditions. The company also announced updated development plans for its investigational Charcot-Marie-Tooth disease therapy FLX-787.
Muscle cramping is due to the uncontrolled and repetitive activation of motor neurons in the spinal cord, which results in sustained muscle contractions. This definition is consistent with that seen in patients with Charcot-Marie-Tooth disorder.
FLX-787 was designed to take advantage of the natural regulatory mechanism of stimulated motor neurons. Taken orally, FLX-787 activates primary sensory neurons in the mouth, esophagus, and stomach. This effect triggers natural inhibitory signals from the spinal cord to other parts of the body. This feedback response is expected to prevent or reduce the frequency and intensity of muscle cramps and spasms.
Flex is initiating the COMMIT Phase 2 trial (NCT03254199) of FLX-787 in patients with diagnosed Charcot-Marie-Tooth disease who have weekly muscle cramps. The trial is endorsed by the Inherited Neuropathies Consortium (INC).
The study will include about 120 participants from 20 study centers across the United States. Participants will randomly receive orally disintegrating tablets of FLX-787 three times daily for 28 days, or a placebo. Enrollment is expected to start during the third quarter of 2017.
In July, the U.S. Food and Drug Administration (FDA) granted FLX-787 fast-track designation for the treatment of severe muscle cramps associated with amyotrophic lateral sclerosis (ALS). It is being studied in a Phase 2 trial (NCT03196375) for this purpose.
“We are encouraged by the Fast Track designation received for FLX-787, one of the most advanced, novel compounds for severe neurological diseases, and look forward to continued collaboration with the FDA in this phase of accelerated clinical development. We are on track to initiate Phase 2 clinical trials of FLX-787 in both ALS and CMT this quarter in the US. These studies will yield important data readouts in 2018,” McVicar said in a press release.
McVicar has been involved in clinical therapy development and pharmaceutical operations for almost 30 years. He served in important roles at companies including Inotek and Sepracor, where he participated in the development and approval of several therapies such as Brovana, Xopenex, and Lunesta.