NMSS, British Partners to Launch Phase 3 Trial to Determine Efficacy of Simvastatin in SPMS Patients

The National Multiple Sclerosis Society (NMSS), together with its British partners, plans to launch a Phase 3 trial in the next few months to investigate whether simvastatin — a cheap drug that controls cholesterol levels — may be a suitable treatment for people with secondary progressive multiple sclerosis (SPMS).

The trial, expected to last six years and cost $7 million, will enroll 1,180 SPMS patients across the U.K. It will receive funding from the NMSS, various British universities and, also in the U.K.: the MS Society, the National Institute for Health Research and the National Health Service.

A previous Phase 2 clinical trial (NCT00647348) with 140 SPMS patients led by Jeremy Chataway, of the University College London Institute of Neurology, showed that the rate of brain shrinkage in people receiving high doses of simvastatin slowed significantly over a two-year period. These patients also reported less disability and better quality of life after the treatment.

“This drug holds incredible promise for the thousands of people living with secondary progressive MS in the U.K. and around the world, who currently have few options for treatments that have an effect on disability,” Chataway said in a press release. “[The new clinical trial] will establish definitively whether simvastatin is able to slow the rate of disability progression over a three-year period, and we are very hopeful it will.”

Added Bruce Bebo, research executive vice-president of NMSS, which is contributing $1.4 million to the effort: “We are very pleased to be a partner in the public-private funding syndicate that was forged to support a Phase 3 clinical trial of a repurposed, generic therapy for people with SPMS, for whom there are few treatment choices.”

SPMS is a second stage of MS that follows relapsing-remitting multiple sclerosis (RRMS). About 80 to 85 percent of MS patients receive an initial diagnosis of RRMS, which is characterized by sudden flare-ups of symptoms followed by periods of remission. Some people eventually transition to SPMS, in which the disease steadily worsens.

Management of SPMS includes drug treatments, appropriate exercise and a healthy diet. When relapsing or worsening of symptoms occur, physical and occupational therapy can help minimize muscle weakness and help restore movement.