What happened to md1003?

[JerryD]

Not 1 word about md1003 and Medday pharma's presentation at this year's AAN annual meeting ? What is wrong with this drug? Does it cause unremitting 'anal leakage'? Or double vision ? lol

[pennstater]

Not sure.

Last thing I read was that it showed slight improvement in EDSS score/timed 25 foot walk for small population. Think it was under 15%. But for about 2/3 of participants, it did slow progression and at 12 month post study, these participants maintained where they were. Which in itself, would be huge for people in progressive phase.

But that was spring time. So not sure. Maybe the study ended to close to the AAN meeting for them to present?

[AMJ]

Last update I read on MD1003

From



Read the entire article, it's very informative, but here are some excerpts. The bolding is my comments.

"Overall, these results show patients in the MD1003 group not only did not progress but even slightly improved within 12 months," commented Dr Tourbah.

Supplement Form

Although biotin is found in some foods, including peanuts, liver, and certain green leafy vegetables, no dietary source is very high in this vitamin. Biotin is also available in supplement form. The usual daily dose is 30 to 100 micrograms.

During the webcast, Frédéric Sedel, MD, chief executive officer of MedDay, warned against MS patients with severe disease rushing off to the health food store or pharmacy to buy biotin. For one thing, it's potentially teratogenic.

"There should be a warning here that pregnant women or those who are planning to become pregnant should not take this drug or very high doses of this vitamin," he said.

As well, unlike the drug used in the study, biotin found on the shelf may be low grade and perhaps not even be biotin. In some cases, said Dr Sedel, patients get vitamin E when they think they're buying biotin.

MedDay will release further results of this phase 3 study, including data on quality of life, fatigue, and other outcomes, at the upcoming European Academy of Neurology meeting in Berlin, Germany. Note this was held June 20th - 23rd, but I havnt seen anything published yet

The company is carrying out another phase 3 study of biotin in patients with MS — including those with relapsing/remitting as well as those with progressive disease — who have vision loss from chronic optic neuritis. After release of those results later this year, the company plans to meet with the US Food and Drug Administration (FDA) to discuss a possible drug approval plan, said Dr Sedel.

This study is still ongoing, the following is excerpt from clinical trial site. We hopefully will hear something soon as the primary completion date was June 2015.

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.

Estimated Enrollment: 105
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

**Moderator's Note - the url given takes one to Medscape log in page only

[JerryD]

Thanks AMJ, that's new info to me . So the upshot is this biotin study hasn't changed anything for us MSers.

[alanpgh]

MD1003 Looks Promsing for PPMS Treatment...

MD1003 looks promising according to data presented at The 1st Congress of the European Academy of Neurology (EAN), held June 20 to 23, 2015 in Berlin, Germany.

See link above and article below:
http://multiplesclerosisnewstoday.co...ple-sclerosis/

I hope this pans out as a valid PPMS treatment. Time will tell.

Please comment if you know anything else about MD1003 or other PPMS treatments in the pipeline.

Thanks,
Alan