Tell us what is happening with new drugs for people with relapsing remitting MS?
This is an exciting times for people with MS if you think about relapsing remitting disease we are just on the cusp of getting a couple of new drugs. Cladribine as a tablet that is used in MS is given in an interesting way, where you take it for two weeks one year and two weeks the next year. Then the data might suggest that two years therapy is good for four years so a very small course of treatment with quite a long lasting effect. That has been through the EMA and has just been approved by NICE so we really should be starting to prescribe it quite soon within the UK and its is going to be used with people who fail on the first line treatments and it does seem to be more effective than some of the earlier therapies.
Just after that ocrelizumab very recently has been given a nod that the EMA is going to approve it for relapsing remitting disease. It is highly effective in relapsing remitting disease and with the kind of efficacy that we see with other antibody treatments like Lemtrada or Tysabri. We've got to see what the EMA's exact wording of the licence is, then its got to go through NICE, which we are expecting next year hopefully. So that's two new big drugs very close together, which is an exciting time.
What about drugs for people with progressive MS?
For progressive disease this has been really the dawn of the treatment era. Ocrelizumab came through as the first drug ever shown to work in primary progressive disease. This is a drug which works very well for relapsing remitting disease and seems to treat some of the inflammation that probably comes early on in primary progressive disease and we see roughly a 20% reduction in disability with that drug. We are waiting to see the precise wording of the licence to know which people with MS will be eligible for it under the licence. Then in the UK, there's then a big hurdle of getting it through NICE, and we're not sure how that is going to go.
Another drug that has shown promise is biotin. This is high dose of a vitamin and you can buy the vitamin over the counter but this is 30,000 times the recommended daily intake and a specially formulated tablet. We see with that in people with a mix of primary progressive and secondary progressive disease that they actually saw an improvement in a number of people over the first year of that and that seemed to be sustained over the next couple of years of follow up. So again that is one that's with the European Medicine Agency at the minute and we are waiting to see whether that will be approved or whether they are going to ask to wait for the results of a second trial.
Then the third drug which is just on that cusp is a drug called siponimod. This is very closely related to Gilenya that we already have for relapsing remitting disease. This has been shown to work in people with secondary progressive disease, reducing the the rate of progressive disability by about 20% over a two year study. This is the first drug that seems to work in secondary progressive disease, with or without relapses. There is a small trial showing that it is also very effective, like Gilenya, in relapsing remitting disease, so we're looking to see where that drug is going to be positioned.
This really is the first time that we've seen anti-inflammatories work in progressive disease. Then with a drug like biotin this is a vitamin that maybe helps the metabolism of the suffering cells which may have an effect as well.
Are there any other drug trials being done for MS?
Along with the new drugs that we have coming along, all of which are new molecules and likely to be very expensive, there has also been a lot of work being done on drugs that are already around to see if we can repurpose them into MS. The one that has probably come furthest is simvastatin. We already have a positive small trial in about 140 people showing that it seemed to slow the rate at which the brain shrunk in progressive disease and a very encouraging indication of a result in disability. Just now as we speak that's getting set up and a bigger trial is getting rolled out round the UK, the MS-STAT 2 trial. It is actively recruiting people with secondary progressive MS. There's a lot of centres in the UK involved, so if people do want to get involved a centre near them will probably be doing it.
There are other small molecules being looked at as well. There's the MS-SMART study, again UK based coming from UCL which is looking at fluoxetine, riluzole and amiloride. Again cheap drugs that are used for other reasons already. We know they're safe, we know you can take them for years and now they're being looked at to see whether they work in MS. Hoping to see results for that trial next year.
Then there is another drug called ibudilast which is an asthma drug that is being used in Japan and again we've just seen the results of a phase 2 trial showing a very significant effect on slowing brain shrinkage in people with progressive MS and also improving the integrity of that brain on MRI scans.
So a lot of small molecules, drugs that are out there and the excitement here is that we don't need to do big expensive safety studies, or long-term studies, because these are drugs we already know.