Potential Progressive MS Treatment on Move in US and Europe, MedDay CEO Says
[URL="https://twitter.com/search?q=%23MSParis2017&src=typd"][U]Potential Progressive MS Treatment on Move[/U][/URL] in US and Europe, MedDay CEO Says
[QUOTE]People with progressive multiple sclerosis are enrolling in a new and global Phase 3 study of MD1003, a high-dose biotin, “about as well as can be expected,” said Frédéric Sedel, co-founder and CEO of MedDay Pharmaceuticals, which is developing the high-dose biotin, a type of vitamin B.[/QUOTE]
[QUOTE]That trial, called MS-SPI2 (NCT02936037), aims to enroll 600 primary or secondary progressive patients with no inflammatory activity at over 80 sites across the U.S., Canada, and Europe. It is essential to the therapy’s potential approval in the United States, Sedel said, having been specifically requested by the FDA.
But — possibly before SPI2 concludes — MD1003 might be an approved progressive MS treatment in the European Union. Sedel confirmed that MedDay has filed for regulatory approval with the European Medicines Agency (EMA) and the company is in discussions with regulatory agencies there.
He anticipates a favorable decision, noting “we strongly believe that we have enough data collected so far for EU approval.”
This data was primarily collected in a smaller-scale, but “similar,” Phase 3 trial of MD1003 (NCT02220933) in non-inflammatory progressive patients called MS-SPI. And, he said, it comes from “real-life” results collected on thousands of people in France who have been using MD1003 under an early access program.
Some 6,500 progressive patients have taken high-dose biotin — of the same quality and at the same dose given in the clinical studies — under this program, giving MedDay access to “a kind of registry … real, live data.”
Information collected largely regards safety, and results are “reassuring,” Sedel said. Simple efficacy points are also being gathered and largely support efficacy data recorded in official trials.
It is important not to overestimate this data, he added, because it’s being collected outside the rigors of a controlled study, and patients can easily come and go, leaving “gaps” in information.
“But,” Sedel said, “I think they give reassurance about the validity of the MS SPI study … [that its] results are honest.”
In the interview, Sedel also talks about the decrease in whole brain and gray matter volume seen in MD1003-treated patients after 12 months, a change he finds quite confounding.
“There is … in first 12 months a quite significant decrease in brain volume, which seems to stabilize after that, so it’s probably not brain atrophy, because brain atrophy is a more long-term process,” he said, adding that, “interestingly,” the loss is also “accompanied or associated with a higher clinical benefit.”
Sedel discusses in detail what researchers think might be its cause, and steps that will be taken in the MS-SPI2 trial to try to better understand the reason for this decrease.
An article about several MD1003 presentations at ECTRIMS can be found by clicking on [URL="https://multiplesclerosisnewstoday.com/ ... -patients/"][U]this link[/U][/URL].
The complete interview with Sedel can be seen below:[/QUOTE]
High doses of biotin in chronic progressive multiple sclerosis: A pilot study.
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Marsei
MedDay’s High-Dose Biotin, MD1003, Improves Disability in Progressive MS Patients
MedDay’s High-Dose Biotin, MD1003, Improves Disability in Progressive MS Patients
[URL="https://multiplesclerosisnewstoday.com/ ... -patients/"][U]De link[/U][/URL] waar in het vorige bericht naar verwezen wordt: #MSParis2017 – MedDay’s High-Dose Biotin, MD1003, Improves Disability in Progressive MS Patients
[QUOTE]
MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France.
The effects of the treatment were seen to be upheld over time and benefitted all patients in the trial similarly, offering hope to progressive MS patients that a new treatment for their condition may be on the horizon.
Presented by a team of researchers in France, the poster titled, “Effect of MD1003 (High-Dose Biotin) for the treatment of progressive MS: 36-month follow-up data,” highlighted robust effects of high-dose biotin over several years.
The MS-SPI Phase 3 trial (NCT02220933) included patients with progressive MS with no inflammatory disease activity. Patients were randomly assigned to treatment with 100 mg of MD1003 three times daily, or a placebo.
In total, 103 patients received MD1003 and 51 were on placebo treatment. Participants in the placebo group (42 patients) were switched to MD1003 after 12 months.
After nine months, 13% of MD1003-treated patients had improved their Expanded Disability Status Scale (EDSS) scores and performed better on the timed 25-foot walk, a measure of mobility and leg function. Meanwhile, none of the patients receiving a placebo had improved. This proportion remained stable over the next two years.
Researchers noted that while the change in EDSS was halted among placebo-treated patients when they switched to MD1003, they remained at a higher level throughout the study, suggesting that earlier treatment is advisable.
At 36 months, 67% of those who received MD1003 throughout the study had experienced an adverse event, compared to 79% of those who first received a placebo.
The team suggested that the effects of MD1003 appear sustainable over time, the drug is able to halt disease progression, and it is well-tolerated.
In a separate poster also presented at the meeting, “Effect of MD1003 (High-Dose Biotin) in spinal progressive multiple sclerosis (MS-SPI): subgroup analyses,” researchers demonstrated that the treatment’s effects were similar for people with primary or secondary progressive MS, or those with high or low EDSS scores in the MS-SPI Phase 3 trial.
The effects were independent of treatment with another disease-modifying drug and of intensive physical therapy.
Finally, the study, “MD1003 in progressive multiple sclerosis: 24-month brain MRI results of the MS-SPI trial,” presented by Douglas Arnold from McGill University Health Centre in Canada, discussed the pseudo-atrophy phenomenon.
Arnold showed that after 12 months, people treated with MD1003 had a lower whole brain and gray matter volume compared to those in the placebo group.
After 24 months, the MD1003 group appeared to have stabilized, while those who had been on placebo for the first 12 months experienced reduced volumes when switched to MD1003, an effect that was maintained in the following 12 months.
No difference in brain volume between the two groups could be detected at 24 months.
Researchers argue that this decrease is linked to a lowering of brain water volume, and may be the result of increased energy production triggered by high biotin doses.
Nonetheless, the results showed that brain energy metabolism is a key factor in progressive MS that can be targeted with high doses of biotin.[/QUOTE]
[URL="https://multiplesclerosisnewstoday.com/ ... -patients/"][U]De link[/U][/URL] waar in het vorige bericht naar verwezen wordt: #MSParis2017 – MedDay’s High-Dose Biotin, MD1003, Improves Disability in Progressive MS Patients
[QUOTE]
MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France.
The effects of the treatment were seen to be upheld over time and benefitted all patients in the trial similarly, offering hope to progressive MS patients that a new treatment for their condition may be on the horizon.
Presented by a team of researchers in France, the poster titled, “Effect of MD1003 (High-Dose Biotin) for the treatment of progressive MS: 36-month follow-up data,” highlighted robust effects of high-dose biotin over several years.
The MS-SPI Phase 3 trial (NCT02220933) included patients with progressive MS with no inflammatory disease activity. Patients were randomly assigned to treatment with 100 mg of MD1003 three times daily, or a placebo.
In total, 103 patients received MD1003 and 51 were on placebo treatment. Participants in the placebo group (42 patients) were switched to MD1003 after 12 months.
After nine months, 13% of MD1003-treated patients had improved their Expanded Disability Status Scale (EDSS) scores and performed better on the timed 25-foot walk, a measure of mobility and leg function. Meanwhile, none of the patients receiving a placebo had improved. This proportion remained stable over the next two years.
Researchers noted that while the change in EDSS was halted among placebo-treated patients when they switched to MD1003, they remained at a higher level throughout the study, suggesting that earlier treatment is advisable.
At 36 months, 67% of those who received MD1003 throughout the study had experienced an adverse event, compared to 79% of those who first received a placebo.
The team suggested that the effects of MD1003 appear sustainable over time, the drug is able to halt disease progression, and it is well-tolerated.
In a separate poster also presented at the meeting, “Effect of MD1003 (High-Dose Biotin) in spinal progressive multiple sclerosis (MS-SPI): subgroup analyses,” researchers demonstrated that the treatment’s effects were similar for people with primary or secondary progressive MS, or those with high or low EDSS scores in the MS-SPI Phase 3 trial.
The effects were independent of treatment with another disease-modifying drug and of intensive physical therapy.
Finally, the study, “MD1003 in progressive multiple sclerosis: 24-month brain MRI results of the MS-SPI trial,” presented by Douglas Arnold from McGill University Health Centre in Canada, discussed the pseudo-atrophy phenomenon.
Arnold showed that after 12 months, people treated with MD1003 had a lower whole brain and gray matter volume compared to those in the placebo group.
After 24 months, the MD1003 group appeared to have stabilized, while those who had been on placebo for the first 12 months experienced reduced volumes when switched to MD1003, an effect that was maintained in the following 12 months.
No difference in brain volume between the two groups could be detected at 24 months.
Researchers argue that this decrease is linked to a lowering of brain water volume, and may be the result of increased energy production triggered by high biotin doses.
Nonetheless, the results showed that brain energy metabolism is a key factor in progressive MS that can be targeted with high doses of biotin.[/QUOTE]
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Sara
Het onderzoek naar biotine als remmer is gestopt:
Het onderzoek naar biotine als remmer is gestopt:
[quote]MS News.
Biotin development stopped
The EMA has announced that Medday have withdrawn the licence application for high dose Biotin.
The EMA were not convinced by the data presented.
The European Medicines Agency (EMA) has been examining data on high dose biotin (MD1003, Qizenday) since the application was accepted in September 2016. The EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the clinical data from two trials that enrolled 253 patients was not sufficient to assess the effectiveness or the safety of biotin. The company reserved the right to re-apply for licensing in the future.[/quote]
Lees meer op:
[url]http://multiple-sclerosis-research.blog ... trial.html[/url]
Dit was nog één van de highlights van het afgelopen ECTRIMS, volgens MSzorgNederland. De ontwikkelingen gaan snel :(.
[quote]MS News.
Biotin development stopped
The EMA has announced that Medday have withdrawn the licence application for high dose Biotin.
The EMA were not convinced by the data presented.
The European Medicines Agency (EMA) has been examining data on high dose biotin (MD1003, Qizenday) since the application was accepted in September 2016. The EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the clinical data from two trials that enrolled 253 patients was not sufficient to assess the effectiveness or the safety of biotin. The company reserved the right to re-apply for licensing in the future.[/quote]
Lees meer op:
[url]http://multiple-sclerosis-research.blog ... trial.html[/url]
Dit was nog één van de highlights van het afgelopen ECTRIMS, volgens MSzorgNederland. De ontwikkelingen gaan snel :(.
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Mulder's Girl
Zijn er vd biotine-gebruikers toevallig ook mensen die een positief effect merken m.b.t. de haargroei op hun hoofd?
Ik was dit supplement al een tijd geleden aan het overwegen, omdat ik ineens heel veel haaruitval kreeg en mijn haar is ook veel dunner geworden.:huilen:
Biotine supplement wordt vaker genoemd voor het hergroeien van (nieuw) haar.
Ik ben er nooit aan begonnen,omdat ik ook las dat hoge dosis biotine een vit.B6 tekort creëert. Daarbij gebruik ik al zo veel supplementen dagelijks...
Ik was dit supplement al een tijd geleden aan het overwegen, omdat ik ineens heel veel haaruitval kreeg en mijn haar is ook veel dunner geworden.:huilen:
Biotine supplement wordt vaker genoemd voor het hergroeien van (nieuw) haar.
Ik ben er nooit aan begonnen,omdat ik ook las dat hoge dosis biotine een vit.B6 tekort creëert. Daarbij gebruik ik al zo veel supplementen dagelijks...
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Mulder's Girl
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Klick
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Mulder's Girl
[QUOTE=Klick;1098889]dat over b6..
loop je dat risico ook met 10,000 mcg biotine per dag?
potje staat nog dicht, haaruitval heb ik wel, ik durf niet zo goed.. bang voor b6[/QUOTE]
Ik weet niet hoe veel 'te veel' is.
Ik denk dat dat verschilt per lichaam. Voor mij is dit idd ook een reden waarom ik geen biotine supplement neem.
Ik neem een B-Complex, daar zit ook een beetje biotine in maar ook B6.....het leek mij beter om een B-Complex te nemen met alle B-vitamines erin, dan een geïsoleerde B-vitamine met als mogelijk gevolg dat je disbalansen gaat creëren.
loop je dat risico ook met 10,000 mcg biotine per dag?
potje staat nog dicht, haaruitval heb ik wel, ik durf niet zo goed.. bang voor b6[/QUOTE]
Ik weet niet hoe veel 'te veel' is.
Ik denk dat dat verschilt per lichaam. Voor mij is dit idd ook een reden waarom ik geen biotine supplement neem.
Ik neem een B-Complex, daar zit ook een beetje biotine in maar ook B6.....het leek mij beter om een B-Complex te nemen met alle B-vitamines erin, dan een geïsoleerde B-vitamine met als mogelijk gevolg dat je disbalansen gaat creëren.
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Klick
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Sara
[QUOTE=Mulder's Girl;1098931]Ik weet niet hoe veel 'te veel' is.
Ik denk dat dat verschilt per lichaam. Voor mij is dit idd ook een reden waarom ik geen biotine supplement neem.
Ik neem een B-Complex, daar zit ook een beetje biotine in maar ook B6.....het leek mij beter om een B-Complex te nemen met alle B-vitamines erin, dan een geïsoleerde B-vitamine met als mogelijk gevolg dat je disbalansen gaat creëren.[/QUOTE]
In sommige multivitamines zit - of zat vroeger in ieder geval - véél te veel vitamine B6, wat tot neurologische klachten kan leiden :(.
Ik neem aan dat jij dat wel gecheckt hebt, maar voor anderen: let daarop alsjeblieft!
Ik denk dat dat verschilt per lichaam. Voor mij is dit idd ook een reden waarom ik geen biotine supplement neem.
Ik neem een B-Complex, daar zit ook een beetje biotine in maar ook B6.....het leek mij beter om een B-Complex te nemen met alle B-vitamines erin, dan een geïsoleerde B-vitamine met als mogelijk gevolg dat je disbalansen gaat creëren.[/QUOTE]
In sommige multivitamines zit - of zat vroeger in ieder geval - véél te veel vitamine B6, wat tot neurologische klachten kan leiden :(.
Ik neem aan dat jij dat wel gecheckt hebt, maar voor anderen: let daarop alsjeblieft!