When will we see the First Oral Drug Approved?

daverestonvirginia · Post by **daverestonvirginia** » Thu Aug 23, 2007 8:46 am

I know there are some of you out there who have a better understanding of this than I do, so lets hear your predictions. I know we have oral laquininod, oral cladribine, fingolimond (FTY720), teriflunomide, and oral fumarate (BG12) all in the late stages of trials, so which one will be first? Also, which one do we think will be the best? Dave

bromley · Post by **bromley** » Thu Aug 23, 2007 9:14 am

Dave,

This is from the US MS Society:

The race for an MS pill

Several oral MS therapies made news last year, bringing hope to the needle-weary.

Oral cladribine: Results from a phase II trial of this immunosuppressive drug by Serono encouraged the FDA to designate this drug as a “fast track product.” This should expedite the review of an international phase III trial now in progress, as soon as the trial is completed. More than 1,200 people are participating in this multi-center trial.

Oral fingolimod (FTY720): A phase II controlled clinical trial in 255 people with active, relapsing MS found that up to 77% of those taking fingolimod remained free of relapses over two years. International phase III trials sponsored by Novartis and involving more than 2,000 people are now underway.

Oral BG00012: A multi-center phase II controlled clinical trial of this immune system modulator, sponsored by Biogen Idec, and Fumapharm AG, led to a 69% reduction in MS inflammation as seen on MRI scans in people with relapsing-remitting MS.

Oral MN-166: In 2005, MediciNova, Inc., launched a phase II multi-center trial in Eastern Europe of an oral drug that may inhibit MS inflammation. Results are expected later this year or in 2008.

Oral SB-683699: A phase II study of 350 people with relapsing-remitting MS was recently launched by manufacturer GlaxoSmithKline. The drug is thought to reduce the number of active white blood cells that breach the blood-brain barrier and enter the brain.

Oral teriflunomide: An open-label, 180-participant, 144-week extension study of this agent, which is believed to modulate T cells, showed that those on placebo during the original trial who switched to the active drug experienced up to an 85% decrease in new, active areas of disease activity as seen on MRI by the final week of the study. A larger study in more than 1,000 people, sponsored by Sanofi-Aventis, is underway.

I think (have read) that the first oral therapies (if the trials prove successful) are likely to be available in 2009 (the earliest date). I think FTY720 looks very promising as it may promote some repair.

The ECTRIMS 2007 conference takes place in early October and the progress on many of these oral therapies is likely to be highlighted.

Ian

dignan · Post by **dignan** » Thu Aug 23, 2007 10:54 am

1. Mylinax completed enrollment for its phase 3 trial in mid-January 2007, so it is clearly in the lead, by 7 months or more. So the trial will end in January 2009. It'll take at least a couple of months to submit everything to the regulator, then I think if the FDA gives a drug priority review status, they try to rule on it within 90 days(? 180 days?). So the absolute earliest approval would be mid-2009.

2. Teriflunomide started its phase 3 trial in 2006 (I think), so if they are recruiting patients as fast as other trials, it should be second to the finish line. 2010 approval at earliest.

3. (tie) FTY720 and BG12 have both started recruiting for their phase 3s in 2007. 2010 approval at earliest.

5. Laquinimod just announced their phase 3 in June, but I don't think they've started recruiting yet. 2010 approval at earliest, but probably not until 2011.

That's the rough order of things as I see them.

Based on the phase 2 results I've seen, FTY720 looks like by far the most promising of this bunch.

One depressing fact to keep in mind, only 40-50% of drugs tested in phase 3 end up winning regulatory approval, so we should only be counting on 2 of these 5 to be available to us one day.

carolew · Post by **carolew** » Thu Aug 23, 2007 5:36 pm

Excellent review guys, thanks. Carole

daverestonvirginia · Post by **daverestonvirginia** » Fri Aug 24, 2007 4:47 am

Yes, I agree with Carole, great overview, Thanks. So next step one or two oral drugs which work better than the current injectionables. Than maybe something like Neurovax or Tovaxin which could stop MS in it's tracks. One step at a time....

CureOrBust · Post by **CureOrBust** » Tue Aug 28, 2007 4:44 am

You can get Aimspro, its not approved or even trialled.

You can get campath, its not approved for MS (But is available for other conditions)

I wonder if any of these treatments will be available before they are approved? anyone know anything?

Jean · Post by **Jean** » Tue Aug 28, 2007 4:54 am

I don't understand : how could they be available without approval ?
Campath has just begun phase III. As FTY720 is not expected before 2009, I think 2010 would be realistic for campath, if everything goes fine. And Aimspro is raising big concerns among MS societies worldwide, about real efficiency. I don't know precisely what's the reason, but if it was to be approved one day, it won't be before quite a long time. And both Aismpro and Campath are injected drugs, not oral.

CureOrBust · Post by **CureOrBust** » Tue Aug 28, 2007 5:05 am

Jean wrote:I don't understand : how could they be available without approval ?

Aimspro is available on "special consent" (and with cash) Thats how daval have gone. ABX's can be prescribed "off-label" by a dr. etc etc

PS I have personally trialled Aimspro and bromley has had campath.

gibbledygook · Post by **gibbledygook** » Tue Aug 28, 2007 8:51 am

Really Cureo, my private quack keeps trying to flog me Aimspro. At least he had the courtesy to reveal he owns shares in the company. Did it do you any good?

craftykate · Post by **craftykate** » Tue Aug 28, 2007 11:41 am

I am on the phase II trial for oral drug Firategrast. http://www.controlled-trials.com/mrct/t ... /A4M105038

Cathie

CureOrBust · Post by **CureOrBust** » Wed Aug 29, 2007 1:48 am

gibbledygook wrote:Did it do you any good?

not really. i have posted my story in the aimspro section

gibbledygook · Post by **gibbledygook** » Wed Aug 29, 2007 9:13 am

thanks, nothing seems to work. Seem to be doing better now am off the metronidazole.

CureOrBust · Post by **CureOrBust** » Thu Aug 30, 2007 1:55 am

I wouldn't say nothing. FTY720 is looking very promising. The only upsetting thing is (as this thread is about) how long before it is available.

Jean · Post by **Jean** » Thu Aug 30, 2007 4:26 am

Members of the french MS research association's scientific comittee told me about 4 years more for getting fingolimod in France : 2 years befire the ending of the phase II trial, a few months for EMEA agreement, and 1 year for the french-equivalent FDA agreement. Last step is very long in France because MS treatments are fully paid by social security (MSers don't need to pay for insurances), so it takes a long time before french government and pharma companies reach an agreement on the price. Besides, our dear french administration is quite slow (euphemism) in France. So you should be able to get it before us in America.

CureOrBust · Post by **CureOrBust** » Mon Sep 03, 2007 2:43 am

I did a search, and found the following in the clinical trials web site.
http://clinicaltrials.gov/show/NCT00239876

Now, what this says to me is that:
1. FTY720 has completed a Phase III trial for another condition.
2. FTY720 might get approval for another condition, meaning it may be available for sale before it is available/approved for MS.
3. Doctors could start prescribing it "Off label" sooner than it is approved for MS.

Thoughts?