#ACTRIMS2018 – MS Therapy MD1003’s Disability Improvements Hold Over Time, Study Shows

#ACTRIMS2018 – MS Therapy MD1003’s Disability Improvements Hold Over Time, Study Shows

MedDay Pharma’s MD1003 leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows.

Researchers presented the results at the third Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, Feb. 1-3. The poster presentation was titled “Effect of MD1003 (High-Dose Pharmaceutical Biotin) for the Treatment of Progressive MS: 36-Month Follow-up Data.

The MS-SPI trial (NCT02220933) assessed MD1003’s ability to improve progressive MS patients’ disability, especially their walking problems. The San Diego presentation focused on the results of a 27-month follow-up to the nine-month trial.

In the trial, researchers randomized patients to received either MD1003 or a placebo, with the treated group consisting of 103 people and the control group 51. After the nine months, 133 patients received MD1003 until month 36.

Researchers checked patients’ disability at the end of the first, second and third years of the study. Two of the yardsticks they used were improvements in patients’ scores on the Expanded Disability Status Scale, or EDSS, and in an exercise capacity test known as TW25, or the time it takes to walk 25 feet. Two other barometers were Clinician and Subject Global Impression scales, which track patient progress and treatment over time.

A key finding was that MD1003 led to significant improvements in patients’ EDSS and TW25 scores at nine months, compared with the placebo-treated patients. The treatment’s benefits held at 18 and 30 months, researchers said.

After the placebo group switched to MD1003 at nine months, researchers saw no differences in new EDSS results between the treated and control groups at months 24 and 36.

But the group that received MD1003 for the first nine months continued to have better cumulative scores than those who initially received a placebo, then switched to MD1003. This suggested “that earlier treatment leads to a lower disability” at month 36, researchers wrote.

Another finding was that at one year the patients who were initially treated with MD1003 performed better in the time to walk 25 feet test than the controls. This held during the follow-up period. In contrast, the performance of the group initially treated with a placebo worsened in the final year.

In addition, the Clinician and Subject Global Impression scale results were significantly better in the MD1003-treated group during the first year, but there was no difference after that.

Patients tolerated MD1003 well during the follow-up study, researchers said. Seventy-nine percent of the placebo group had experienced adverse effects at three years, versus 67 percent of the treated group.

Overall, the results suggested that the improvements seen in the group that was initially treated with MD1003 lasted over time. In addition, the findings suggested that patients who switched to MD1003 after a year on the placebo saw their disease progression slow — although the delay in the start of their treatment led to them having more disability over time.

24 comments

  1. John Rush says:

    Interesting as this is slightly different than research released at ECTRIMS this year:

    http://www.mdalert.com/ms/ectrims/article/highdose-biotin-increases-inflammation-and-relapse-in-ppms

    You have one poster session, this article citing, ACTRIMS presented research, saying Biotin slows disability and ECTRIMS (link I include above) urging caution – made things worse, at least as measured by MRI and relapses.

    ECTRIMS – smaller sample and measuring relapses and MRI activity
    ACTRIMS – no info on whether they used MRI or just monitored changes in 25TW test. Makes me wonder about disclosures/sponsors and whether Biotin good or bad. Should I be taking?

  2. nancy says:

    I have taken 100mg of Biotin for 9 months, stopped for 2 weeks becauseI wasn’t sure if it was doing any good……..big mistake. I was so much more disabled,and immediately resumed taking it. It is compounded for me, since every brand I looked at only came in micrograms.

      • Jenny says:

        You need to take 300MG of High dose Biotin.
        1 month is not enough time for some people. Clinical trials have shown that it can take 9 months.
        I buy the high dose biotin 300MG from skipspharmacy.com for a fair price. It is working for me and I have secondary progressive MS.

    • Doug says:

      I was under he impression that the required/suggested dose was 300mg…which is what I have been taking for just over 2 years now. I haven’t seen much if any improvement, but I also read that three years out was when the “epiphany” moment should happen…not far to go, will hang in unt4il then

    • Jenny says:

      I buy the high dose biotin 300MG from skipspharmacy.com for a fair price. It is working for me and I have secondary progressive MS.

  3. Susan says:

    YES YES YES! I increased the amount of Biotin I took when I read about the apparent impact seen in the French study, and I have seen improvement in my day-to-day fatigue level, cognition and movements. I found pharma grade B7 on Amazon – in a powder form, and I just add it to either food or beverage once a day. Oh, and I “progressed” to SPMS six years ago.

  4. Sandra D says:

    With no DMT for PPMS etc on the horizon, the vitamin Biotin is all we have. Hope is better than despair. I’ve take 300mg daily for 3 months now and I think it has helped in small ways. Difficult to measure. The days are so variable. My brain fog and some bladder issues seem improved. No adverse effects noted. My EDDS score is 6-7. 10 years diagnosed. My older sister has RRMS. It costs $100 a month for me in Australia. Compounded pharmacy. No rebates from private health funds. Am I surprised?…

  5. Beth L Schurman says:

    Please note that biotin must be stopped one week prior too any thyroid function testing. Get grossly interferes with the test results.

  6. Sandra says:

    What dose of biotin is considered effective? Is it a vitamin that builds up in your system that can damage your liver, kidneys, heat etc?

    How does biotin help, cellular level?

  7. Jenny says:

    I buy the high dose biotin 300MG from skipspharmacy.com for a fair price. It is working for me and I have secondary progressive MS.
    in the 6 months I have been taking it so far I have:
    – more energy and can walk up the stairs again and use escalators.
    – I do not have to use any mobility devices because I no longer drag my left foot
    – I am able to go shopping again and my left hand is getting stronger and I am now able to use it again to eat etc.

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