Phase 3 trial involving more than 1,000 people with multiple sclerosis will investigate whether inexpensive drug could become a treatment
The British trial will cost almost $7 million and is being funded by a collaboration of the National MS Society (U.S.), the MS Society (U.K.), the National Institute for Health Research (U.K.), the National Health Service (U.K.), and U.K. universities.
The trial will test simvastatin, an inexpensive cholesterol lowering drug, in people with secondary progressive MS (SPMS). There are currently no licensed treatments that target disability progression in people with SPMS.
The research will be led by Dr. Jeremy Chataway, University College London Institute of Neurology, who led the phase 2 trial of simvastatin involving 140 people with SPMS that was published in The Lancet in 2014. The research found those taking high doses of the drug had a significant reduction in the rate of brain atrophy (brain shrinkage) over two years, and also had better disability and quality of life scores at the end of the study.
“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,” said Chataway. “This study 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.”
Bruce Bebo, Executive Vice President, Research for the National MS Society said, “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.”
The simvastatin trial begins in Spring 2017, and will involve 1180 people with SPMS across the U.K. The trial will take six years to complete.
The trial will cost a total of nearly $7 million, with research costs of:
• $1.8M National Institute for Health Research (U.K.)
• $1.4M MS Society (U.K.)
• $1.4M National MS Society (U.S.)