Annovis Bio gets US FDA clearance to begin pivotal phase 3 studies of buntanetap

[ZebraDoodle]

“The phase 3 program will investigate buntanetap in patients with early Alzheimer’s disease and will consist of two clinical trials: a 6 months study aimed at confirming buntanetap’s symptomatic effects and an 18 months study designed to demonstrate potential disease-modifying effects. While the Company plans to run both studies, the completion of a well-designed and well-executed 6 months clinical trial may be sufficient to support new drug application filing, potentially within one year of the study’s initiation.”

pharmabiz.com/NewsDetails.a...

[park_bear]

Maria stated that they would be talking with the FDA about both Alzheimer's and Parkinson's next steps at the FDA meeting. Lack of mention of the Parkinson's program suggests that the FDA meeting did not go well in that respect.

[MarionP in reply to park_bear]

The request for extension into an additional 18 months was done because the data discussed at the open company conference call meeting, which I personally listened to, had disappointing data in the first place thus requiring either an additional study extension or perhaps giving up which they certainly didn't want to do with investors on the line. This is a hail Mary salvage operation. It remains to be seen if they are in bed in an unspoken manner with FDA and FDA is winking back. But business is business, and that's where the FDA is these days. So the FDA may be planning to "review it and then we will hide our decision under subjective opinion" approval once they have a good enough pretext. Possession of the authority is 10/10ths of the law, and they can withstand the temporary static the non-business community or competitors may generate. I hope the eventual data is legitimate because the current data was not at all promising, it was disappointing which is why the company came up with the idea to ask FDA for a little more time by extending the study. But it also means it didn't work in the first period so adding 18 months at customer expense and time they maybe don't have left in their lifetime my not fly unless there's a Republican administration (meaning that it still could happen with Democrats, they like lobbyists just as much, just a little more uncertainty with them).

[WinnieThePoo in reply to park_bear]

All the FDA have really done is to say "the drug looks safe. You can carry out another trial , on the following basis, to try to prove it works, if you want to." If they have the money to do so. The new trial population, to be dug out of the post-hoc analysis, is a bit more convincing for AD than it was for PD. In truth, both PD and AD trials were outright direct fails - and would have been ranked as such by a serious pharma, not desperate to find a use for the only molecule they have. And if you are going to pick a stream to invest your limited funds, pick AD where there is no competition at all for symptomatic relief (so you might get an NDA with a 6 month trial) rather than PD where there is plenty of existing symptomatic relief and you probably need an 18 month disease modifying trial to get an NDA). Each 18 month trail is probably going to cost between $50 million and $100 million

[peminc]

Still awaiting news on PD studies. No mention of an open label study for prior participating.