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BIogen AD Drug v. PBT2, page-11

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k273

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24/03/15

04:13

Post #: 14965558
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Originally posted by interestingtome ↑

Hi K- I have some concerns about this data. Firstly, the safety issues are very concerning to me especially since the highest ARIA-E issues were seen in the ApoE sub population (55%) and this group comprises the majority (generally 60-75%, 77% in the IMAGINE study) of the AD population. So this means that the drug won't be able to be used on 60-75% of the AD population and FDA would probably not allow it in a trial. Also,

1- Baseline SUVR was 1.4 – that’s not really even mild AD population
2- Inverse MMSE dose response results obtained for the 3 mg and 10 mg dose groups (0.75 and 0.58 points, respectively) makes me think the 3 mg dose just faired better due to less edema?
3- The 6 mg dose response at half way read was the same as the placebo. No other 6 mg results are reported yet and why? Perhaps the data show no improvement at all.
4- Only stat significant results on the CDR-SB for the 10 mg dose (group that showed highest ARIA-E) and this is the measure that FDA is most concerned with. They won't be able to use this dose in the ApoE4 population.
5- Drop outs were significant and the dosing groups in the high dose lost more people and likely affected the results in the 10 mg dose group and maybe the 6. While the overall n=166 by the time that was split into each dose group and the placebo and then accounting for the dropouts the dose groups look really small. Way smaller than the IMAGINE trial.
6- the placebo group worsened more than it should normally - this is very important because it probably means that the results for SUVR and CDR-SB appear to be better than they should when you do the between group comparison. If IMAGINE were compared with this placebo group we would likely be looking at a whole different world. I just don't like the fact that the 6 mg data were not reported past the interim look - and the interim look made the 6 mg look no different than the placebo.

Thats some of my issues with it. In a fair world, I think they will be hard-pressed to get FDA approval to move forward with a phase 3 trial in any subgroup (non ApoE4 or carrier) due to the safety issues. I've seen reports that 20% edema rates would be OK . This is a bit perplexing as we are sitting with FDA having a partial clinical hold on PBT2 for a drug that has a much better safety record. Then Biogen doesn't have approval yet either yet so we will see. If Biogen were a one drug company I would short the heck out of it ;-)

I hope that answers your questions or perhaps I have run on too much ...if not please ask.

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Further to our previous:

http://www.marketwatch.com/story/st...-but-some-worry-about-overreaction-2015-03-20

I was interested in the last two paragraphs. Are these BP companies able to influence the FDA at all.

PBT Price at posting: 14.5¢ Sentiment: None Disclosure: Held
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BIogen AD Drug v. PBT2, page-11

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BIogen AD Drug v. PBT2, page-11

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