MedDay’s MD1003, a Biotin, Shows ‘Remarkable’ Efficacy in Treating Inactive but Progressive MS in Clinical Trials

MedDay’s MD1003, a Biotin, Shows ‘Remarkable’ Efficacy in Treating Inactive but Progressive MS in Clinical Trials

MedDay recently disclosed full study results from the MS-SPI and MS-ON Phase 2b/3 trials of its therapeutic candidate MD1003 in patients with multiple sclerosis (MS). Specifically, the trials included people with “not active” progressive MS and those with either relapsing or progressive MS and visual loss, respectively. Data, presented at the recent American Academy of Neurology 2016 Annual Meeting in Vancouver, Canada, demonstrated better efficacy in reversing disease progression than a drug has previously achieved in not-active progressive MS.

MD1003 is a pharmaceutical formulation of high-dose biotin, a type of vitamin B. The drug, which is already commercially available in certain European countries under early access programs, has previously shown efficacy in patients with progressive MS. It acts in MS by increasing a route of cellular energy production, protecting against the breakdown of nerve cell axons. It also activates enzymes that are setting the pace on myelin repair by being involved in the production of myelin constituents.

The MS-SPI trial, focusing on not-active progressive MS, a difficult-to-treat form of the disease, explored the effects of MD1003 in 103 patients, compared to 51 others who received placebo during 12 months. The study continued in a 12-month extension phase, during which all patients received the drug but remained uninformed of whether they had been treated with MD1003 in the first phase.

MS-SPI met its primary endpoint — the proportion of patients who improved on either the Expanded Disability Status Scale (EDSS) or a timed walk test. MedDay reported improvement in 12.6 percent of patients after nine months, confirmed at 12 months, and equivalent to a reversed progression. During the same period, none of the placebo-treated patients improved.

During the extension phase, patients who had been on MD1003 from the start continued improving, with 13.2 percent of them demonstrating less disability at 18 months, and 15.4 percent at 24 months.

“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,” Professor Ayman Tourbah at CHU de Reims, France, and the studies’ principal investigator, said in a press release. “In addition, if we look at the mean Expanded Disability Scale (EDSS) change, the data compare very favorably 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.”

Meanwhile, the MS-ON study included patients both with relapsing-remitting (RR) MS and progressive disease. The group consisted of 64 RRMS patients having a fixed visual loss after an acute inflammation of the optic nerve, and with 31 patients with progressive visual loss. During its first phase, running for 24 weeks, 65 patients received MD1003, and 28 received placebo. The first part was followed by an additional study period of 24 weeks, during which all patients received the active drug.

The study found that patients treated with MD1003 improved their eyesight slightly more than placebo-treated patients, but the difference was not statistically significant. Further analysis revealed that only the patients with progressive disease benefited from the treatment.

The studies also demonstrated good safety and tolerability data for MD1003.

“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,” Professor Tourbah said.

“Taken together, these studies are very promising and provide hope for a condition that has thus far been largely intractable using treatments targeting neuroinflammation,” added Professor Bruce Cree at University of California, San Francisco, and the principal investigator in the prospective U.S. study of MD1003. “That the extension study from the SPI trial showed an apparent durability of effect suggests that high dose biotin may have disease-modifying properties in addition to its proposed role in enhancing energy metabolism.

“Furthermore, the positive impact of high dose biotin points to a new line of inquiry in understanding the pathophysiology of progressive MS,” Professor Cree concluded.

74 comments

  1. Shasha says:

    I take 5000mcg of biotin daily in addition to coenyzmated B vitamins and Vit B12 methylcobalamin shot daily. The 5000mc of biotin helps give circulation to my toes and help the Citric acid cycle/Kreb’s cycle which helps the mitochondria make ATP energy. Less the 5000mcg did not help. 5000IU of Vit D3 also help and fish oil 2000mg/2000mg of evening primrose oil/2000mg of lecithin and more good oils…Vit C/Zinc/Mg/probiotic/HCl and enzymes with meals/Vit A 10,000IU/rhodiola/coenzyme Q10/Nature’s plus- Source of life multiple and more. B vitamins get Mg working which get K (potassium) into cells. Biotin is not just for strong nails/hair, but energy/oxygen/circulation for the cells.

        • spiro says:

          But is not nearly enough to get this benefit. Please do the math and anecdotal evidence about your diet and supplements have no value in research

          • John Nauss says:

            I beg to differ, anecdotal evidence, as you call it, is evidence that this person has or is being helped. In science there is no such a thing as “no value in research” but of course, if you are a dogmatist run by Big Pharma, then that is a different point of view; one bolstered up by believing that it is the final source no matter what and if nothing can be found by you, then nothing can be found by anyone else. “We” will keep looking Meanwhile, in the actual world of others who know our bodies, take responsibility, we carry on and enjoy good health till the end, instead of suffering, and brain fog, pain, depression and a deteriorated body. We are programmed for health, not sickness. You’ve got it wrong. I may die of it, but it won’t be so tragic.

        • Rick T says:

          Hi Shasha,
          I just started biotin a month ago on, more or less, a speculative hope that it would help. I have started with 1000 2x a day morning and night. My question, what brought you to the conclusion that 5000 + is required ?
          Thanks in advance for your reply ☺

      • Kathleen says:

        Whether she has MS or not, I wish she would keep her “nonsensical pseudoscientific comments” to herself. As a scientist myself (with PPMS), the fallacies are glaringly obvious. This or that “may” help, with no facts to back it up, are just opinion, not science. And she is using so many supplements and dietary modifications that there is no way to tell which, if any, of them are actually effective.

        I am referring here not only to this post, but also to her posts on other articles, which are many, often lengthy, and decidedly not helpful. She’s entitled to her opinion, but it’s not science and I, for one, am tired of hearing it.

        • Sonya says:

          This is from NCBI.gov.
          CONCLUSIONS: These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going.

    • christine Bauman says:

      I started taking 100mg 3 x a day last Oct and have improved. My Nuerologist is testing me again tomorrow. I am going for the football field walk, I think I can do it. I will let you know. This is huge for me as I walk almost unassisted on short distances. I pray to continue improving. Hugs Christine Bauman

          • Ken Bloom says:

            Thank you Susan. Your recommendation is the only one that mirrors the clinical trial

            highdosebiotin.net offers 100mg pharma grade biotin. Anything else and you will not be following the clinical trial protocol. Your call but this is the best place, quality and price that I’ve found.

      • Ina-Maria says:

        Dear Christine, I am really interested in your experience with biotin. You say you have improved. Can you give me some more details?
        I am a 56 year old woman from Germany with PPMS. 5 years ago my walking started to get worse. It’ s my left knee and foot that do not work properly. I can walk – with difficulties – for 500 metres – and then I have to rest for a -longer – while. There are some other minor problems ( my left hand is weaker) but I can manage. I am very much interested in biotin and your experience. I am looking forward to your answer.
        Thanks in advance.
        Ina-Maria

      • Christine Bauman says:

        I forgot I posted here and now I can walk twofootball fields, I am doing amazing. I do run out of energy and still have fatigue days but nothing like I used to. I also have weakness in my right hip flexster.

        • Megan says:

          Hi Christine hope you are doing well
          Can u tell me how much biotin are you taking and where did you buy it
          Thank you

  2. Mike says:

    If the results are remarkable, why are they running a third phase III? Why are they not pursuing FDA approval so those of us who are suffering with this horrible disease might be able to find a little bit of relief.

      • Terry says:

        Hi Paul. It’s my understanding that the FDA is requiring this additional trial specifically in the US. It’s supposed to be managed by the Neurosciences Dept at U of San Francisco Med Center if I recall. I sent an email to them earlier in the year to see if I could be one of the trial participants and they said they would put me in their file for consideration. Haven’t heard a word. They had no idea at that time when it would even begin. So, not MedDay’s delay. Our good old FDA.

  3. Soeren Rasmussen says:

    Please refer the study correct: You refer
    “MedDay reported improvement in 12.6 percent of patients after nine months, confirmed at 12 months”
    12.6 percent doesn’t sound as very much but the correct interpretation is “Proportions of patients in each treatment arm:
    – with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5)
    or
    – with improved TW25 of at least 20% at Month 9 and Month12
    compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)”
    source: clinicaltrials.gov – search md1003
    That means that patients have to improve with 1 or 0,5 EDSS-score to count as improved in the study. Probably did most or all patients improve on MD1003. In the non-blinded pilot trial before the blinded trial 21 out of 23 patients had some form of improvement of their sclerosis. The 2 patients which did not improve had a EDSS-score of 8,5. Probably out of reach of terapeutical range.

    • Spiro says:

      Hi Soren, can you explain this interpretation a little better for me? It is difficult to follow the reasoning.

      Thank you

  4. Paul says:

    I just purchase pharm grade pure bulk Biotin (No fillers so it takes very little) and take 100 mcg 3 X a day. That is what MD1003 is. I truly believe it helps with my numbness in my hands and foot. When I cycle off of it for 6 weeks my numbness comes back. A week back on and it fades away. I also take Alpha Lipoic Acid and many of the other items listed by Shasha. I have RRMS and also take Tecfidera. I know the study didn’t find any benefit to RRMS but the population of RRMS is so diverse. I have spinal chord lesions and have read in other studies that Biotin helped spinal chord involvement. Unfortunately the also noted a non significant increase in lesion size.

    • Shasha says:

      No need for pharm grade…regular supplements work awesome in me. I need 5000mcg of biotin once a day and also take coenzymated B complex. 1000mcg did not help…2000mcg did not help…3000mcg did not help…4000mcg did not help. It was not until I got to 5000mcg that circulation happened in my toes and it helped my MS. I can’t be 1 1/2 months without it. Alpha lipoic acid with meals helps glucose/food get into the mitochondria. MS that comes and goes maybe due to what a person is eating eat day. MS plaques/scars went away with my protocol and LDN which helps block hidden gluten. Gluten may hurt the gut lining so food and supplements may not absorb well. It may take 1 1/2 months to heal the gut lining once gluten is stopped, but within 2 weeks of 100% no gluten I had 1000X more energy and felt 20 years younger and health was stable.

      • undisclosEd says:

        Shasha,

        The protocol for Biotin in these trials is 100mg, 3 times per day of 100% pure pharmaceutical grade Biotin. You are not taking anywhere near that amount, or quality.

          • It is available on Amazon.com, and they also sell a small electronic (~$20) mg balance for accurate dose weight. Also they sell 100 mg (not mcg) capsules by Ace Pharma. That’s what I am taking, 1 100 mg capsule three times per day. I asked my primary care doc before starting, and he told me it couldn’t hurt, so go for it. It’s been only 1 1/2 months now, no improvement yet, but I’m in it for the long haul, as the studies indicate it takes months to see improvement, and meanwhile, there is nothing else out there for PPMS. (Please correct me if I am wrong.)

      • Wawoc says:

        I agree. I also take 5000 mcg of biotin, since july 2016. I was at 2 on EDSS last year. I do not take anything else, no medication. Today, my EDSS is at 0. I also change my alimentation and banned titanium dioxyde of my life (because i’m allergic). After some research, i’ve banned ALL colorant of my alimentation, medication and pharmaceutical products (soap, shampoo, makeup..) I think colorant are a factor in multiple sclerosis and others neurologic diseases as demonstrated in Europe research.

    • Christine says:

      I have already started the Alpha Lipoic Acid, I started and then brought it to my Neurologist attention for feedback. My biotin was self started at 5000 mcg/day and just started 100 mg 3x day today. Do you know the recommended Alpha Lipoic Acid? I am finding I am the only person making more holistic recommended choices – which is normal in medicine in my opinion.

      • Peter says:

        The protocol for the ALA is 1200 mg twice a day (2400 mg daily). I’ve been taking it almost one year and so far so good.

  5. Steve says:

    The next phase III kicks off in September this year. trying to find out if they will have a branch in the US.

  6. spiro says:

    I was under the impression that it may be FDA approved by late 16 OR early 2017. If starts in September,were looking at another year. There is No reason for another phase III trial. European people are same as US last I checked. This is ridiculous.

      • spiro says:

        I believe it’s the US regulators that are demanding a US phase III trial, not meday. Either way, another wasted year

    • Fredance says:

      I was a project manager in Pharma industry (Bsel,CH)
      I have PPMS aswell and was fired last year
      One of the key differences between US and Europe is that FDA always require a placebo control but the EMEA is very reluctant to administer placebo medication to patients. This is most likely the explanation why they had to dedign a specific additional study for the FDA

      • Tim Bossie says:

        We are sorry to hear about the loss of your job and your struggle with PPMS. Thank you for your insight into this. It is true that the FDA is quite strict with their guidelines and acceptance of new treatments.

  7. mike says:

    trials are expensive even the small ones. The manufacturer would much rather start selling than run another trial. Their stock will go up more once they come to market. I was in that industry for 40 yrs and I cannot justify their ethics and morals, from a profit perspective they would be better $ wise off not doing another trial. It is the FDA which is requiring the phase three trial.

  8. Terry says:

    I also take 5000 mcg (micrograms…not milligrams) of Biotin. Started because Tecfidera made my hair start falling out and affected liver values. I am very anxious to try 300 milligrams of Medday’s product. But once again, our good old FDA makes bringing new drugs to market difficult, expensive, and the wheel has to be re-created according to FDA standards. FDA needs to fast-track this…I would be more than happy to trade bodies with them so they can get a taste of life with MS. Maybe that would light a fire under them!

  9. David says:

    So why not take a bulk supplement of Biotin.. this has been used for the last 1.5 yrs. or we can wait till we are all disabled. I ain’t. Godspeed. Dave

    • spiro says:

      Because people need to understand, this is NOT OTC biotin in a higher dose. It is a special pharmaceutical grade biotin with different chemical ligands to increase bioavailability. People that at have blown upwards of $600 a month through compound pharmacies have learned the hard way that it had no efficacy. Sadly, that’s how science works.

    • Shasha says:

      5000mcg of biotin on Amazon helps me. This is the amount that makes circulation in my toes. Less doesn’t work the same. I need much more than biotin. I need Zinc/Mg/fish oil/Vit C/HCl and enzymes/probiotic when stomach acid is low/Nature’s plus- Source of life multiple/Vit B12 methylcobalamin shot/intrinsic factor kind/MTHF folate/coenzymated B vitamins/coenzyme Q10/rhodiola/lecithin/evening primrose oil/Vit D3 5000IU and much more for my MS.

  10. Elaine says:

    Hi, I have SPMS and have been taking D-Biotin 100mg three times a
    day. I get the pills which are pure Biotin from a pharmacy which
    is located in Connecticut. They have a website MetaBiome.com
    where you can easily order online. I just bought three bottles,
    90 capsules in each, for $158. And yes, I have definitely had
    some improvement. I have been doing this for three months.
    There are also several sites on Facebook that you can join for
    more information. Just put biotin in their search box.

    • Jorge Castillo says:

      Elaine, I hear ya, MS 32 yrs, DMDs many, presently Tecfidera x 3 1/2 yrs ,100% pure Biotin x 100mgs x 3/day,for 1&1/2 yrs monitored regularly by neurologist.It’s helped and continues, quality of life Greatly Improved. FYI, I do follow a group on FB and I’m taking the study dosage of 100/Milligrams per/day Not micro grams. I live in the real world. I do walk with a cane. If one starts reading what some people write one might think they probably believe in CCSVI too and I don’t. Take care, your MS friend,feel free to contact me.

      • Rachel says:

        Have had MS for 16 years. Started out RRMS but is gradually turning into SPMS. On Copaxone for 14 years. Switched to Tecfidera two years ago. Was told about Biotin (B7) last week. Read 2015 study which showed some improvement with B7 using dosage range between 100mg to 600mg, with a median of 300mg which they said was the best therapeutic dose. The effect is statistically significant but very small: very little improvement on the EDSS (-.03). On the other hand, the control group continued to get worse (+.13 on the EDSS). So B7 seems to slow down progression and maybe even improve symptoms a little. Which is a first for the PP or SP group.Decided to try it. Only available in 5 or 10,000mcg doses in stores, so went online to find 300mg capsules. The 2015 study found improvement after 2 to 8 months, so we will see what we will see.

        • spiro says:

          Yes, agreed. Small effect on improvement but it’s to be expected when axons are lost, not much can be done. Even if biotin remyelinates, it would have little effect on damaged axons. But, I will take slowing down of the damage or stopping in progressive phase any day

          • Rachel says:

            First off, the (median) therapeutic dosage from the study is 300 mg / day. Since 1 mg = 1,000 micrograms, and since the usual store bought capsules are in micrograms, it would take an impossibly high number of those capsules to reach the therapeutic range. You need to buy Biotin in the milligram (mg)dosage and not the microgram (mcg) dosage.

            We have found two sites which sell Biotin in 100 mg capsules:

            https://highdosebiotin.net/
            http://www.naturalcompounder.com/high-dose-biotin-2/

            May the re-myelinating odds be ever in our favour.

        • Ellen says:

          I just had a compound pharmacy make up 90 100 mg capsules of USP D-biotin for my spouse who suffers with PPMS, after coming across those studies. We will see what happens – any improvement will be fantastic. He just started Friday and is taking three per day to total the 300 mg.

        • Christine says:

          I was taken off Tecfidera this week, lymphocyte count went to low in 15 months. started the biotin at low dose, due to hair loss that I am reading about with others here. Now the next option is Abagio, which is known for hair loss, but is apparently one of the other oral meds, and known for hair loss.I did not know until this week biotin is good in slowing MS progression, I don’t understand why I was the one to recommend it to my Neurologist. Only just diagnosed July 2015, only 1 “attack” but with remaining major numbness.

  11. nanu says:

    I have SPMS and just picked up 100 capsules of 300mg biotin, from my compounding pharmacy. Will begin taking this evening, hoping for some mobility improvement in 3 months. My EDSS score is 6, and I am 66 years ago. After this, I will try ESTRIOL, 8MG/day. Currently take Ampyra 2’s/day.

    • Spiro says:

      That’s great you’re starting on Biotin but you’re looking at 9 -12 months before seeing some improvement, if any. Three months may be a bit ambitious but you never know

    • Rachel says:

      Am seeing significant results for Ampyra – improved walking. Next time I see my neurologist, I’m going to discuss it with him. There are actually three or four promising drugs out there for PPMS or SPMS, which is a lot better than it used to be.

  12. Jorge Castillo says:

    Hello I’ve been on biotin 100 mg three times a day sinceJune 13, 2015 it helps me with Bowel and bladder control. I also noted on the studies that it helps some people with visual problems presently I only have optic neuritis and if biotin can provide neural protection for my eyes that’s more than enough for me although of course I hope for more. Have a great day

  13. Lisa Scroggins says:

    Does anyone know if biotin in the “required” (300 mg/day) can cause unwanted effects? I figure I don’t have much to lose, having progressed from a cane to a rollator in a year. Stopping the progression would be a huge win. I am going to start this.

    • Rachel says:

      Most sites say there are no side effects. Note however that there aren’t too many – any? – studies at the very high dosages used in the MS research. One site said there might be an allergic reaction to the fillers – whatever they are. Another site said it might make acne worse because it competes for receptors with another B vitamin. But overall it seems to be as neutral and side-effect free as you could hope for.

  14. Rachel says:

    Big concern now is whether a drug company will take out a patent on high dose Biotin and price it in the same range as other MS drugs of proven effectiveness. Right now we can buy high dose Biotin online for about $60 for 90 100mg capsules which is doable – for example at http://www.naturalcompounder.com/high-dose-biotin-2/
    However, most RRMS drugs cost thousands per month. Although Biotin does not seem to work on RRMS, I can see how manufacturers would want to get in on the PP or SP MS market. I have seen one patent application for high dose Biotin so far: as far as I can tell, what makes it different from the Biotin we can already get is a) it is time-released and b) it is available in injectible form. Whether that is sufficient for it to be patentable I do not know.

    https://www.google.com/patents/WO2014016003A1?cl=en

    • Rachel says:

      Not a physician or biochemist. But since it appears to be readily excreted by the kidneys, I’m guessing in order to keep a therapeutic level – whatever that may be – need to take it several times during the day. But you really need an expert’s opinion.

        • Martin EDSS 8 says:

          I have not been able to find the dosing schedule and although I am aware of its short half life and elimination time I wonder if the therapeutic effect occurs in divided doses, or massive 300mg once a day doses are required?

  15. Tina says:

    Had a visit with my Neurologist Tuesday and we discussed my options of new drugs. We landed on Biotin and she told me to begin taking 100mg daily, 50 mg twice daily.

    • Danielle says:

      Can anyone elaborate on the difference between biotin supplements purchased over the counter vs the “pure” biotin discussed in these comments? I have had RRMS for 18 years and signs of SPMS the past several years. I started aubagio almost 2 years ago which made my hair fall out. This is when I started biotin. I take 5000 mcg once daily of the otc variety but have no clue how this might compare to the levels in the test. Any insight? Thanks!

      • Rachel says:

        As Ed noted, you need 100 mg 3x a day (median dose in the study) The 5,000mcg you’re taking is the equivalent of 5 mg. You have take 20 times that 3 times a day. A lot of pills to take unless you can locate a supplier who does provide 100mg doses. Information about sources is available higher up on this thread.

        PS Sorry about the side effects of your meds. They all have side effects – mine made my violently nauseous to begin with, along with flushing. Those subsided, but two years down the line I developed a new side effect: intense itching. Thankfully that responded to benadryl and/or loratidine!

  16. Ed says:

    If you are trying to duplicate the MedDay trials you need to be taking 100mg of 100% pure Biotin, 3 times per day. For more information join the Facebook group Biotin For Progressive MS

  17. nd says:

    Bulksupplements.com carries 2 different biotin, the 1% is cheap, $40 for 100g. It’s the same as what you find otc everywhere, 1% biotin and 99% filler.

    They also carry the pharm grade pure, it’s a bit more expensive at 189 for 100g. But you have to remember the medday dosage comes down to about 1/64th a teaspoon per pill to get 100 milligram dosage. That $189 will last you a year or so at 3 pills per day.

    When I first heard of biotin I just dropped the dose into a water bottle. It was less than convenient. Then I bought a gel capsule machine and if memory serves 00 size caps gives about the right size dose.

    Since every person is unique in regards to muscle mass, bone bass, metabolism etc and the recommended dose is not tailored to anything, just 300mg per day, every person on the study is working in the ‘about’ range. So +/- is good enough.

  18. Laurence says:

    My wife was diagnosed in 1987. She has SPMS and at 9 on the disability scale. In October of 1998 she got out of bed and dropped to the floor she hasn’t walked since. She has slowly gone downhill in April of 2006 she had surgery for a bowel obstruction and ruptured appendix and lost some speaking ability and use of her left arm and hand. We heard about Biotin from the local compounding pharmacy so we tried it starting in Sept of 2016, I start with 1000 mcg. 3 times per day. We notice minor changes within a month, when up to 5000 mcg 3 times per day and by the end of October I notice she was able to move her left arm up but not move it back down her speaking was also clearer. We then tried 10000 mcg from Amazon again noticing some minor improvement but we were not at the recommended dose. We just purchased the 100mg size from the compounding pharmacy she says we should increase slowly start with 1 per day for 1 month then 2 then 3 pills per day at meal times. Right now she speaks better is more alert (less brain fog) and may never walk again but to communicate and maybe be able to feed her self again would be amazing.

  19. Kristin says:

    Any one looking for a 100 mg supply go to; metabiome.com. They have a sliding scale the more you buy the less you pay. 1 bottle $49.95 -90 capsules, a one month supply . 3 bottles $44.95 , 6 bottles $39.95.

Leave a Comment

Your email address will not be published. Required fields are marked *