It is hoped that the study – the third and final phase of the trial into the drug simvastatin – will lay the foundations for an effective SPMS treatment, which is currently lacking.
The MS-STAT2 trial will involve 1,180 people with SPMS and confirm whether simvastatin could slow or stop disability progression in SPMS cases, offering new hope to thousands. MS affects over 100,000 people in the UK, and most expect to develop a progressive form of the condition.
Positive results from a smaller trial showed simvastatin – currently used to treat high cholesterol – could improve levels of disability and slow disease progression.
It also reduced the rate of brain atrophy (shrinkage), suggesting the treatment could protect nerves from damage in SPMS. Recruiting for the trial will run until the end of 2019 across almost 30 sites – including those in London, Sheffield, Leeds, Edinburgh, Poole, Glasgow, Belfast, Dublin, Nottingham, Cambridge, Manchester, Cardiff and Exeter.
Bruce Barrett, 40, who lives in Oxfordshire with his wife and two sons, hopes to participate. He says: “I live with uncontrollable tremors, which means everyday activities like brushing my teeth and getting dressed are really difficult. This trial gives me a lot of hope – if it leads to a new treatment for SPMS, it could completely change my quality of life. It might mean one day I could kick a ball around the park with my boys, rather than sit in a wheelchair watching them.”
Jeremy Chataway, a consultant neurologist at UCLH who is overseeing the trial, said: “Simvastatin is a very promising treatment prospect for secondary progressive MS in our lifetime. People with this form of the condition have been waiting decades for a drug that works, which is why there’s such excitement around being able to start the trial. While it’s still early days, we believe simvastatin could change lives.”
The multimillion-pound trial is being funded by the MS Society in collaboration with the National Institute for Health Research, the National MS Society (US), the NHS and UK universities.
Dr Susan Kohlhaas, Director of Research at the MS Society, said: “We are incredibly proud to be funding MS-STAT2, because we know what it could mean for people living with progressive MS. This condition is unpredictable, painful, and often exhausting, but finding an effective therapy means debilitating symptoms aren’t inevitable.
“Today if you’re diagnosed with this form of MS you don’t have any options, but we’re getting closer to changing that, and hopefully delivering the solution everyone has been waiting for.”
Meanwhile, researchers in America have found positive signs that the promising drug ibudilast could limit the impact of progressive MS.
Their phase two trial, published in the New England Journal of Medicine, showed that the drug decreased progression of brain atrophy in progressive MS patients by 48 per cent versus placebo. The two-year SPRINT-MS study was conducted at 28 sites with 255 patients.
Principal researcher Robert Fox said: “Our hope is that the benefit of ibudilast in slowing brain shrinkage will also translate to decreased progression of associated, physical disabilities in a future phase 3 trial.
Ibudilast, an oral drug with activity on several biologic pathways with potential relevance to progressive MS, was approved in Japan in 1989 for use in asthma and stroke. It is also being studied in the US for potential treatment of drug addiction and motor neurone disease.