AnnovisBio has initiated a 6-month, placebo-controlled, double-blind Phase 2 study to evaluate efficacy, safety, & tolerability of 2 different doses their agent Buntanetap (posiphen) in 450 participants with #Parkinsons
AnnovisBio has initiated a 6-month Phase ... - Cure Parkinson's
AnnovisBio has initiated a 6-month Phase 3 study to evaluate 2 different doses Buntanetap (posiphen) in 450 participants with PD
12 Replies
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Oh boy life gets confusing. I'm sure it was early this year that the news was the fda had approved phase 3 trials following successful phase 2 trials450 participants is a big phase 2
in reply to WinnieThePoo
at least it is a 6 months study...
Is "Phase 2" a typo?
This looks very similar to their Phase 3 trial outline posted a couple of days ago.
healthunlocked.com/cure-par...
in reply to jeffreyn
yes, you might be right....both are enrolling 450 patients, could it be a coincidence?
jeffreyn in reply to
It's not just the "450 patients" that is the same.
"The Company announced the trial design of the upcoming Phase 3 trial evaluating buntanetap in early PD. The study is designed to enroll 450 PD patients with Hoehn & Yahr scale scores of 1, 2 and 3 and randomize them at 1:1:1 ratio into placebo, 10mg or 20mg buntanetap once daily on top of their standard of care for six months."
irpages2.eqs.com/websites/a...
in reply to jeffreyn
fixed the title to say phase 3.
In the title they say "double-blind", but in the "Brief Summary" they also say "open-label".
"The total duration of open-label study participation will be 6-7 months."
I assume that means 6 months double blind followed by 6-7 months open label.
yes it was a typo, they fixed it to Phase 3
They have changed the completion dates to something more realistic.
Estimated Primary Completion Date: June 2023
Estimated Study Completion Date: December 2023
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