I would like to know the status of DDP225 for IBS-D I see from press reports that Phase II was started in Oct 2005 and the trials were for 8 weeks. SO what are the results? Has phase III commenced. I also notice that Astellas has acquired the R&D arm of Dynogen including DDP225 So any info on that?
DDP225
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Raghavan,I think it takes a long time typically for patient recruitment so this trial might very well be still going on. Also, I believe this is only a phase IIa trial, which still leaves another phase IIb trial before they can even get to phase III. I would also suspect that they may try to license this product or sell it outright to a larger company, which could present further delays. And that is assuming it is even effective, a fact which has yet to be established. This drug is years away under the best of circumstances, I think. Also, I did come across that Astellas article and I believe the deal did not involve the purchase of this compound. Sorry I couldn't be more encouraging.
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Yep the do not run all couple of hundred or so Phase II people the same 8 weeks. They usually have a couple of testing sites that can handle a small number of patients at a time, so the # of weeks is not the entire length of the study. It is 8 weeks for the individual, but if you only do 20 at a time and you need to do 2-300 that is a lot of weeks.They won't start Phase III until after Phase II is complete and evaluated and it shows promise. Phase III takes even longer because it is usually a few thousand people. They do more at a time most of the time as they tend to have more testing sites. Once Phase III is complete it is usually about a year from being available at most pharmacies. Phase III in progress to market is usually in the 2-4 years of being on the market. Phase II is going to be more like 4-6. Assuming all goes well, the drug works the regulatory agency doesn't want more tests to check for some side effect. With IBS type of things there also seems to be the whole you can treat it with fiber you don't need drugs prove to me anyone even needs this drug there are more side effects than fiber alone hurdle which seems politically to make it harder than usual to get these drugs to market. This tends to bog the process from Phase III complet to getting it on the shelf part of the process.K.
The phase IIa results are finally (!) in for DDP225 and they look impressive. It appears to have beaten the placebo by a very wide margin. The only bad thing is that the next stage is probably only phase IIb and not phase III, meaning it is still quite a few years from market (assuming future studies go well, of course.)http://www.businesswire.com/portal/site/go...amp;newsLang=en
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