Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Posiphen · 2 trials · 3 indications
Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group
Number of adverse events or study discontinuations, broken down by dose arm (i.e. Low vs. Medium vs. High vs. Placebo), and further broken down by relatedness to Posiphen (Definitely Related, Probably Related, Possibly Related, Unlikely Related, Unrelated)
Mean plasma concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine their concentrations.
Mean CSF concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine the concentrations.
The fractional synthesis rate (FSR) of Aβ40 was measured in the CSF using the SILK™ technique. FSR is a measure of the rate of Aβ synthesis in the brain. During 13C6-leucine infusion, 13C6-leucine is incorporated into newly synthesized proteins throughout the body, including the brain, in proportion to the available 13C6-leucine. This FSR is calculated as the rate of change of the ratio of 13C6-leucine-labeled Aβ proteins to unlabeled Aβ proteins in the lumbar CSF between 6 to 16 hours, normalized to the ratio of labeled to unlabeled leucine amino acid in plasma. It is reported as a fraction of 13C6-leucine-labeled to unlabeled Aβ proteins per hour. The ratio of Aβ in CSF containing 13C6-leucine to that containing unlabeled leucine is measured using mass spectrometry.
| Arm | Type | Description |
|---|---|---|
| Posiphen, 80mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
| Posiphen, 40mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 40mg, taken once per day for 25±2 days. |
| Posiphen, 20mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 20mg, taken once per day for 25±2 days. |
| Posiphen, 10mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 10mg, taken once per day for 25±2 days. |
| Posiphen, 5mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 5mg, taken once per day for 25±2 days. |
| Placebo (Parkinson's Participants) | PLACEBO_COMPARATOR | Placebo Oral Capsule, taken once per day for 25±2 days. |
| Placebo (Alzheimer's Participants) | PLACEBO_COMPARATOR | Placebo Oral Capsule, taken once per day for 25±2 days. |
| Posiphen, 80mg (Alzheimer's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
| Low Dose | EXPERIMENTAL | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
| Medium Dose | EXPERIMENTAL | The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
| High Dose | EXPERIMENTAL | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
| Placebo | PLACEBO_COMPARATOR | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. |
| Name | Type | Description |
|---|---|---|
| Posiphen | DRUG | Solid oral dosage form, capsule |
| Placebo | DRUG | Solid oral dosage form, capsule |
Inclusion Criteria Subjects must meet the following criteria: 1. Male or female aged 45 years and over. 2. Female participants must be of non-childbearing potential or post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophor...
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Posiphen is an investigational small molecule developed by Annovis Bio, Inc. (ticker ANVS) for Alzheimer disease. It is a Phase 1 clinical-stage candidate in the neurology therapeutic area. Posiphen has been studied in two completed Phase 1 trials with a combined enrollment of 93 participants.
Posiphen is being developed for the treatment of Alzheimer disease. Its clinical program has focused on early Alzheimer disease, with one trial also including Parkinson disease patients. Posiphen remains investigational and has not been approved for any indication.
Posiphen is developed by Annovis Bio, Inc., which trades under the ticker ANVS. The company sponsors the clinical development program for Posiphen in Alzheimer disease and related neurodegenerative conditions.
Posiphen is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both have been completed. Posiphen is investigational and has not received FDA approval for Alzheimer disease or any other indication.
Posiphen has been evaluated in two completed Phase 1 trials. NCT04524351 was a dose-finding biomarker study in early Alzheimer and Parkinson disease patients with 75 participants. NCT02925650 examined safety, tolerability, pharmacokinetics, and pharmacodynamics in 18 subjects with early Alzheimer disease. Both were conducted in the United States.
Yes. The Posiphen Phase 1 program used randomized, double-blind, placebo-controlled designs. The two completed trials enrolled a total of 93 participants, with NCT04524351 enrolling 75 and NCT02925650 enrolling 18. Participants were adults with early Alzheimer disease, and NCT04524351 also included Parkinson disease patients.