AnnovisBio has initiated a 6-month Phase 3 study to evaluate 2 different doses Buntanetap (posiphen) in 450 participants with PD

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

clinicaltrials.gov/ct2/show...

twitter.com/ScienceofPD/sta...

[Boscoejean]

location?

[Hidden in reply to Boscoejean]

clinicaltrials.gov/ct2/show...

[WinnieThePoo]

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

[Hidden in reply to WinnieThePoo]

at least it is a 6 months study...

[jeffreyn]

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...

[Hidden in reply to jeffreyn]

yes, you might be right....both are enrolling 450 patients, could it be a coincidence?

[jeffreyn in reply to Hidden]

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...

[Hidden in reply to jeffreyn]

fixed the title to say phase 3.

[jeffreyn]

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.

clinicaltrials.gov/ct2/show...

[jeffreyn in reply to jeffreyn]

They have changed this sentence to now say "The total duration of study participation will be 7-8 months."

[Hidden]

yes it was a typo, they fixed it to Phase 3

[jeffreyn]

They have changed the completion dates to something more realistic.

Estimated Primary Completion Date: June 2023

Estimated Study Completion Date: December 2023