At the recent American Academy of Neurology (AAN) conference, MedDay provided an update on their trials into the use of their biotin compound (MD1003) as a treatment for multiple sclerosis (MS). In particular, they reported on the results of the MS-SPI trial (testing MD1003 in people with non-active progressive MS). The highlights of this trial were:

  • In this cohort, MD1003 significantly reversed disease progression compared to the placebo across the first 12 months. This benefit was sustained through a further 12 months of treatment. This was measured by a timed 25-foot walk.
  • These findings were also supported by the mean EDSS of the groups with small but significant changes observed. A slight decrease in EDSS was observed in the MD1003 group compared to an increase in the placebo group.
  • MD1003 was well tolerated with similar adverse events reported between both groups.

MedDay also reported on the results of the MS-ON trial, a study that aimed to look at the effect of MD1003 in people with both progressive disease and those that hadn’t recovered from an acute relapse. This was done by recruiting people that had either had acute or progressive optic neuritis or visual loss over the past 3 years. The results showed a moderate benefit of MD1003, however, it did not reach statistical significance. It was discussed that potentially statistical significance would have been reached if only people with progressive optic neuritis had been studied.

In speaking about these studies, Professor Ayman Tourbah said “Full results of the MS-SPI study are especially remarkable. This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients. In addition, if we look at the mean Expanded Disability Scale (EDSS) change, the data compare very favourably with all previous trials that looked at the same endpoint. Almost no progression was observed in patients treated with MD1003 for 24 months and this has never been observed before. When we compare these results to other trials in progressive MS that involved more than 6000 patients overall, this is clearly the best effect size ever observed. The MS-ON trial failed to reach its primary endpoint but this is most likely due to a majority of patients with relapsing remitting MS in this trial. Indeed if we focus on patients with the progressive chronic neuropathy phenotype, they seem to have benefited from the drug in the same way as patients in the MS-SPI trial. Results from both studies are therefore consistent and point to the fact that targeting neuron and oligodendrocyte metabolism represents a promising and novel disease modifying therapy approach in progressive MS, particularly in patients with a not-active progressive disease.”

We are currently in the process of organising an interview with Dr Frederic Sedel, who is also heavily involved in this process. If you have any questions for Dr Sedel, please comment below and we will do our best to ask them during the interview.

You can read more about this study here.

5 Responses

  1. Barry

    How does this Bioton differ from Biotin already avilable on the market?

    Reply
    • MStranslate

      Hi Barry,

      Thank you for your question.

      MD1003, which is the compound that medDay are using in their trials, is an oral formulation of high-dose pharmaceutical grade biotin. The dose being used in the trial is 300mg, which is 10,000 times higher than the adequate intake.

      At the end of the video, we discuss the fact that biotin is readily available and whether people with MS should begin to take it themselves. As Dr Sedel mentions, there are many reasons why he wouldn’t recommend this yet and will want to see the full results of the trial before that is a possibility.

      Regards,

      Brett

      Reply
  2. Rob darwin

    Hi was wondering if I could be considered for this trial and in your opinion could benefit ?
    I would very much so like be a part of this trial unfortunately I am not very good at steps with a walker

    Reply
    • MStranslate

      Hi Rob,

      Thanks for your interest in this piece and the ongoing trial. To clarify, MStranslate is a science communication initiative that is designed to provide information for people with MS about current research.

      As such, we aren’t directly involved with the biotin trial, we were purely helping provide some coverage of the study. The trial is being conducted by MedDay, so they would be the best people to respond to your request.

      You can email them at contact@medday-pharma.com and use the subject “MD1003 for MS”. Hope this is useful.

      Kind regards,

      Brett

      Reply
  3. Jenny S

    I am SPMS but no MS drugs ever helped me so I stopped taking them in 2016.
    I started taking high does biotin 300mg in October 2017. I no longer have to use any mobility devices because my walking and energy level have improved.
    You can buy it online from amazon or skipspharmacy.com

    Reply

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