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Crohn's expert flags blockbuster potential--and frets--of Celgene's mongersen

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Posted 3/22/2015 11:03 AM (GMT 0)
That's very enthousiasting for Crohn


www.fiercebiotech.com/story/crohns-expert-flags-blockbuster-potential-and-frets-celgenes-mongersen/2015-03-19

www.nejm.org/doi/full/10.1056/NEJMoa1407250?query=TOC&&
Posted 3/22/2015 12:44 PM (GMT 0)

jeanloup said...
That's very enthousiasting for Crohn


www.fiercebiotech.com/story/crohns-expert-flags-blockbuster-potential-and-frets-celgenes-mongersen/2015-03-19

www.nejm.org/doi/full/10.1056/NEJMoa1407250?query=TOC&&

Thanks.
Posted 3/22/2015 8:35 PM (GMT 0)
Wow

The data were released earlier, but it's worth repeating. In the 40-mg and 160-mg mongersen groups, 55% and 65% of the patients hit the primary endpoint, compared to only 10% in the placebo arm and a statistically equivalent 12% response in the low-dose 10-mg arm.

The Crohn's expert also noted that "the remission rates of between 55 and 65% for the two highest doses are unprecedented when compared with those reported in the large pivotal induction studies of infliximab (Remicade) (32.5% glucocorticoid-free clinical remission at week 6 in the SONIC trial), adalimumab (Humira) (36% clinical remission at week four in the CLASSIC-I trial), and more recently, vedolizumab (Entyvio) (14.5% clinical remission at week 6 and 39% at week 54 in the GEMINI 2 trial), all of which also involved patients with moderate-to-severe active Crohn's disease."
Posted 3/22/2015 9:14 PM (GMT 0)
Is this being tested as a UC treatment as well?
Posted 3/23/2015 6:01 AM (GMT 0)
In addition to the great remission rates posted by iPoop, another thing to note about this drug is that the recipients only took it for two weeks and their remission lasted much longer than that.

I hope these results keep up, because the possibility of having a drug you'd only need to take for a little while every few months to keep up remission would be so welcome. It would definitely be a game changer. Hope if the results continue, they can start developing this drug for UC as well.
Posted 4/17/2015 7:24 AM (GMT 0)
The problem is the drug releases in the right side of the colon and most of us UC-ers have left-sided issues. One GI dr. told me that it is ok because as long as it releases in the colon it can still go to the left side and another GI dr. told me that it needs to be re-formualted for left-sided colon patients. Anyone have any idea?
Posted 4/17/2015 11:36 AM (GMT 0)

Indycat23 said...
Is this being tested as a UC treatment as well?

not presently. uc response in pre-clinical studies was not promising
Posted 4/17/2015 10:07 PM (GMT 0)
How soon can we expect it to hit the market?
Posted 4/18/2015 2:54 AM (GMT 0)
DBwithUC - do you have a link to the study?
Posted 4/18/2015 4:04 AM (GMT 0)
I read something in a business report last year about unclear results for UC, but I do not have a link. I tried to find the report.

I do see other business reports that think it could work for UC. See: www.investorvillage.com/smbd.asp?mb=341&mn=187507&pt=msg&mid=13795608

so maybe if it hits market in 2018 it will get prescribed off label for UC.

Post Edited (DBwithUC) : 4/17/2015 10:15:25 PM (GMT-6)

Posted 4/18/2015 4:20 AM (GMT 0)
The TGF-Beta that the drug targets should have made it attractive for UC too. see www.ncbi.nlm.nih.gov/pubmed/23489130 - but they went with CD only.

I thought I had read that the initial safety data was better for CD, but I can't find whatever I read.
Posted 4/18/2015 4:30 AM (GMT 0)
I did find a reference that said the Smad7 pathway the drug targets was elevated in all CD patients but not all UC patients:

" the gut
tissues from CD patients and most UC patients also expressed higher levels of Smad7"

investorshub.advfn.com/boards/read_msg.aspx?message_id=103915146
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