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Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease

JMC

JMC

Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease

I had my regular quarterly hospital check up today and the gastroenterologist I saw mentioned this paper as an exciting development:

http://www.nejm.org/doi/full/10.1056/NEJMoa1407250

CONCLUSIONS
We found that study participants with Crohn’s disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo.
 
S

shepz

Great to see! I know it's hard to predict things like this but does anyone know when this might hit the market? Are we talking 5 years? 10 years?
 
xeridea

xeridea

shepz said:
Great to see! I know it's hard to predict things like this but does anyone know when this might hit the market? Are we talking 5 years? 10 years?
Click to expand...
Your 5 year guess is probably in the right ballpark. They're currently recruiting for the next phase trial in US with results publishing in 2017 at earliest. Then there might be additional trials and regulatory approvals.

We had a little more in-depth discussion on this drug here if you're interested.
 
xeridea

xeridea

Here is some trial updates.

Celgene is currently doing a more rigorous trial they term CD-001 that uses a more rigorous endoscopic assessment as opposed to CDAI scores to gauge efficacy. Divided into five phases, (screening, induction, observation, extension and follow-up), 48 patients will participate in this study that is designed to last 97 weeks. Endoscopic response and durability of response will be measured during the first three phases, and that can last up to 69 weeks. These are blinded phases so no data will be released until the last patient completes that 3rd phase, so 2017 we'll see these preliminary results.

On other fronts, a larger phase III trial of 2,000 patients will start enrollment soon.
 
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