Bitopertin addendum

In looking at the Roche bitopertin trial design, the six month readout in the negative symptom trial protocol was the primary endpoint, not an interim measure. The second six month timeframe was an ‘extension within protocol.’ The suboptimal responder trials focused upon positive symptoms appear to have their primary endpoint readout at three months, with a nine month extension. Thus one might shave off a little time from the previous post’s guesstimates on readout timing for those three trials, though of course, we have no definitive information about rate of enrollment– we had heard rumors that enrollment was going slowly.

The other unknown is whether any effect might be expected on cognitive symptoms. From the Phase II results we have seen, we would suspect no significant differentiation was found there, since the CNS-VitalSigns neuropsych results were the one category not highlighted. Thus it is unlikely that a Phase III effect will fortuitously emerge, though Roche will dig deep to see if there is anything to be found.

It is also worth noting that, while the PhII used doses of 10, 30, and 60mg (with 60mg doing the worst), this Phase III program did not go above 20mg.

This entry was posted in Uncategorized. Bookmark the permalink.

One Response to Bitopertin addendum

  1. Tx Gue says:

    Hi,I really love your website because the information on neuro research drug is very complete.i am a schizophrenic with bad cognitive and negative symptoms,besides bitopertin and evp-6124(encinecline) is there other kind or different a meds or molecule that might help my condition?plus do you know when will evp-6124 probably be launch if phase 3 is successful?dorecast launch in 2016,is it gonna be even late for drug bitopertin since it fail 2 out of 6 trial already?

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s