When we think about pharmaceutical companies and clinical research, usually we picture scientists and doctors developing new medications, and usually for diseases that are regularly reported on, such as cancer.
In this case, though, the National Institute for Health Research, or NIHR, is starting a phase 3 clinical trial examining the effects of a drug already in common use for other things, Simvastatin, on people suffering from multiple sclerosis.
Statins and MS
Multiple sclerosis is a degenerative autoimmune disease, meaning the disease gets worse and progresses over time, and, effectively, it causes an individual’s immune system to attack their healthy cells, causing damage.
MS causes the immune system to damage the nervous system, eventually causing intermittent or permanent loss of the ability for the brain to communicate with other parts of the body, eventually causing some loss of motor function.
Statins are a class of medication, including Simvastatin, that are normally prescribed to those with high cholesterol or hardening arteries, but they have secondary effects of reducing inflammation, and possibly protecting the nervous system.
These studies into Simvastatin as a defense against MS progression are relying on those secondary effects. The nerve shielding properties of Simvastatin has been shown in early trials to reduce the brain degeneration caused by MS, and substantially better outcomes were observed, when compared to a placebo.
How clinical research works
There are two phases to most clinical research. The first involves more stereotypical lab work, which is focused on identifying a new potential medication, or a new application for a pre-existing medication, as with Simvastatin.
Once a medication has been developed, there may be some degree of animal testing, to ensure safety before beginning human clinical trials. Human trials may include paid medical trials, such as those run by http://www.trials4us.co.uk/, where volunteers with certain conditions or a healthy background are paid to trial the medication over a longer period, to test safety and efficacy in a ‘real world’ setting.
In the case of Simvastatin and MS, a 140-person phase 2 study has been completed with positive results, so researchers are now moving on to a 1,180 person phase 3 study, hoping to have full results, and a new MS treatment, by 2023.