Annovis Bio have published the results of their dose-finding, biomarker study of buntanetap in 14 early Alzheimers & 14 Parkinsons patients

have published the results of their dose-finding, biomarker study of buntanetap (known as Posiphen or ANVS401) in 14 early #Alzheimers & 14 #Parkinsons patients; A Phase 3 for PD is currently recruiting (NCT05357989)

Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer’s and Parkinson’s Patients

link.springer.com/article/1...

[park_bear]

Short duration: "A total of 68 AD and PD patients were treated for 25±2 days."

"Buntanetap at all doses improved patients’ Part III scores. We observed the best improvement after buntanetap treatment with 10mg and 20 mg QD, statistically significant improvement compared to baseline (Figure 3A)."

UPDRS part III image credit: https://link.springer.com/article/10.14283/jpad.2022.84

[Router_ in reply to park_bear]

interesting data - and as they suggest themselves, they were surprised by the effect on updrs scores after such a short treatment duration. They seem to suggest themselves that this is rather a symptomatic treatment effect than a disease modifying one - however implying that they are confident that buntanetap will also have disease modyfing properties. will be really interesting to see long-term data from the phase 3

[park_bear in reply to Router_]

They did suggest that, but it works by reducing αSYN so I would call it disease modifying:

"By suppressing APP, tau and αSYN synthesis, we hypothesize that buntanetap normalizes the levels of these toxic proteins and re-establishes proteostasis, rescues axonal transport and endosomal function, and staves off nerve cell death and neurodegeneration"

[Hidden in reply to park_bear]

Thanks for this quality discussion.

[park_bear in reply to Hidden]

Now recruiting for Phase III: clinicaltrials.gov/ct2/show...

Study details include: The double-blind treatment duration will be up to 6 months. Over 30 study locations actively recruiting throughout the US. See above link

"Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.

2. H&Y score =1, 2 or 3 during ON-state & OFF-state <2hrs per day...."

en.wikipedia.org/wiki/Hoehn...

H&Y 3: "Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent"

" 450 early Parkinson's Disease (PD) patients will be randomized to 10mg, 20 mg of Buntanetap or placebo. They will undergo a Screening Visit, and if they provide informed consent and are considered eligible per the inclusion and exclusion criteria, will proceed to participate in the treatment period. Randomized participants will visit the clinic for the first-time dosing in clinic with administration of 10 mg or 20mg of Buntanetap or Placebo, followed by an at home dosing period of 6 months, with daily administration of 10 mg or 20mg of Buntanetap or Placebo. Participants will be required to visit clinics 1 month, 2 months, 3 months, and 6 months (end-of-trial), where they will undergo study procedures that include safety assessments (AE and concomitant medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments, and physical examinations) and psychometric tests (MDS-United Parkinson's Disease Rating Scale (MDS-UPDRS), Clinical Global Impression of Severity (CGIS), Wechsler Adult Intelligence Scales (WAIS), Mini-Mental State Examination (MMSE)) and Participant Global Impression of Change (PGIC). At the end of blood sampling, the subjects will need to stay for a minimum of 1 hour of observation. After all end-of-study procedures are complete, the subject will be discharged to home. A 24-hour follow-up call will occur after all clinical visits to assess the participants current condition and if there are any additional adverse events to report."

Planning on putting an additional post with this info.

[Canddy]

This link has the participating centers:

beta.clinicaltrials.gov/stu...

under "Contacts and Locations"