What Is buntanetap/posiphen?
buntanetap/posiphen is an investigational medication currently undergoing study in clinical trials. It is being developed by Annovis Bio Inc. and is administered as a capsule taken by mouth. The specific way buntanetap/posiphen works in the body (its mechanism of action) is not detailed in the provided trial descriptions. However, it is being explored for its potential therapeutic effects in various neurological disorders.
Clinical research is focused on understanding how buntanetap/posiphen may impact conditions such as Alzheimer Disease and Parkinson's Disease. This drug has been studied in a total of 4 clinical trials, involving a combined enrollment of 2,134 participants. The first trial began in 2022, with the latest trial projected to conclude in late 2025. The medication is typically taken as a single capsule once daily. The capsules themselves are made with HPMC (hydroxypropyl methylcellulose), which is a vegetarian-sourced material.
Uses and Conditions Under Study
buntanetap/posiphen is currently being investigated in clinical trials for several neurological conditions. These studies aim to evaluate the drug's safety and effectiveness in managing symptoms and progression of these diseases.
One primary area of investigation is Alzheimer Disease. This progressive brain disorder causes problems with memory, thinking, and behavior. buntanetap/posiphen is being studied for its potential to help manage or slow the progression of this condition, including trials specifically focused on Early Alzheimers Disease. A total of 2 trials are exploring the drug's role in Alzheimer's-related conditions.
Another significant focus for buntanetap/posiphen is Parkinson's Disease (PD). This is a progressive nervous system disorder that affects movement, often causing tremors, stiffness, and difficulty with balance and coordination. The drug is being investigated for its potential benefits in both general Parkinson's Disease and specifically Parkinson's Disease, Idiopathic, which refers to cases without a known cause. A total of 2 trials are dedicated to studying buntanetap/posiphen in Parkinson's Disease.
Additionally, buntanetap/posiphen is being studied in relation to Deep Brain Stimulation. This condition involves a surgical procedure to implant electrodes in specific areas of the brain, typically used to treat movement disorders like Parkinson's disease, essential tremor, and dystonia. One trial is exploring the potential interaction or complementary role of buntanetap/posiphen in patients undergoing or having undergone Deep Brain Stimulation.
Dosing
buntanetap/posiphen has been studied in clinical trials in various dosage forms and strengths. The medication is administered orally as capsules.
The capsules are made with HPMC (hydroxypropyl methylcellulose), which is a vegetarian-sourced material. Participants in clinical trials have typically taken buntanetap/posiphen once daily.
Several strengths of buntanetap/posiphen have been investigated to determine the most effective and safest dose for different conditions. These include:
- 7.5 mg buntanetap/posiphen capsules
- 10 mg buntanetap/posiphen capsules
- 15 mg buntanetap/posiphen capsules
- 20 mg buntanetap/posiphen capsules
- 30 mg buntanetap/posiphen capsules
One specific trial protocol mentioned a dosage of 30 mg by mouth once daily for 18 months. The exact strength prescribed would depend on the specific condition being treated and the results of ongoing clinical research.
Side Effects
In clinical trials, the most commonly reported side effects for buntanetap/posiphen included:
- Nausea: 4.6% of patients taking buntanetap/posiphen experienced nausea, compared to 2.8% of patients on placebo.
- Fatigue: 4.0% of patients taking buntanetap/posiphen experienced fatigue, compared to 2.8% on placebo.
- Dizziness: 2.7% of patients taking buntanetap/posiphen experienced dizziness, compared to 1.1% on placebo.
Clinical Trial Results
Early Parkinson's Disease (PD)
A double-blind study (NCT05357989) investigated the efficacy and safety of buntanetap/posiphen compared with placebo in participants with early Parkinson's disease over 6 months. Key outcomes included changes in motor and non-motor symptoms.
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Cognitive Function (MMSE): For participants with baseline Mini-Mental State Examination (MMSE) scores between 20 and 28, the 10 mg dose of buntanetap/posiphen led to an average improvement of 0.65 units from baseline, and the 20 mg dose led to an average improvement of 0.45 units. In contrast, participants on placebo experienced an average worsening of 0.50 units on this scale, where higher scores indicate better cognitive function.
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Motor Symptoms (MDS-UPDRS Part III): All groups showed improvement in motor symptoms as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, where lower scores indicate better motor function. The 20 mg dose of buntanetap/posiphen resulted in an average reduction of 2.66 units from baseline, while the 10 mg dose showed an average reduction of 1.04 units. Participants on placebo experienced an average reduction of 2.90 units.
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Daily Living Activities (MDS-UPDRS Part II): For activities of daily living (MDS-UPDRS Part II), where lower scores indicate better function, the 20 mg dose of buntanetap/posiphen showed an average reduction of 0.04 units from baseline. The 10 mg dose showed an average increase of 0.57 units, indicating a slight worsening. Placebo showed an average reduction of 0.10 units.
Mild to Moderate Alzheimer's Disease (AD)
A dose-ranging study (NCT05686044) evaluated the efficacy of buntanetap/posiphen in participants with mild to moderate Alzheimer's disease over 12 weeks.
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Cognitive Function (ADAS-Cog11): For biomarker-positive participants with baseline MMSE scores between 21 and 24, all doses of buntanetap/posiphen showed improvement in cognitive function as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11), where lower scores indicate better cognition. The 30 mg dose led to an average reduction of 3.32 units from baseline, the 15 mg dose to a reduction of 2.79 units, and the 7.5 mg dose to a reduction of 2.19 units. In this subgroup, placebo showed a smaller average reduction of 0.26 units.
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Overall Cognitive Assessment (ADAS-Cog11, general population): In the broader study population, the 15 mg dose of buntanetap/posiphen resulted in an average reduction of 3.01 units on the ADAS-Cog11 scale. The 30 mg dose showed an average reduction of 2.24 units, and the 7.5 mg dose showed an average reduction of 1.34 units. Placebo resulted in an average reduction of 2.32 units.
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Activities of Daily Living (ADCS-ADL): As measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, where higher scores indicate better ability, placebo showed the largest average improvement of 2.03 units from baseline. The 15 mg dose of buntanetap/posiphen showed an average improvement of 1.71 units, and the 30 mg dose showed an average improvement of 0.15 units. The 7.5 mg dose showed an average worsening of 0.14 units.
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Plasma Biomarkers: Changes from baseline to Week 12 in plasma biomarkers were observed with the 30 mg dose of buntanetap/posiphen, showing average changes of -985.1 pg/ml, 2.1 pg/ml, and -2.5 pg/ml. For comparison, placebo showed average changes of 5.5 pg/ml, -467.5 pg/ml, and 0.4 pg/ml for the same biomarkers.
Currently Recruiting Trials
Researchers are actively seeking participants for new clinical trials investigating buntanetap, also known as Posiphen, for neurological conditions. These studies aim to understand the safety and effectiveness of this potential new treatment.
One ongoing study, NCT07284784, is a Phase 2/3 trial focused on the long-term safety of buntanetap in individuals with Parkinson's Disease (PD). This open-label safety study is designed to last 36 months and will involve two cohorts. Cohort 1 is specifically for PD participants who have previously taken part in buntanetap clinical trials and will be enrolled by invitation only. The study aims to enroll 500 participants, including those with Deep Brain Stimulation.
Another significant trial, NCT06709014, is a Phase 3, double-blind study evaluating the safety and efficacy of buntanetap in participants with early Alzheimer's Disease. This trial seeks to determine if buntanetap/Posiphen can improve cognition, as measured by ADAS-Cog, in adults aged 55 to 85. It also aims to gather comprehensive safety information. This study has an enrollment target of 760 participants.
Where to Participate
Clinical trials for buntanetap/Posiphen are being conducted across a wide geographic area, making participation accessible to many. There are currently 102 sites located in 93 cities across 33 states. Some of the top locations with multiple sites include:
- Chicago, Illinois (4)
- Aventura, Florida (2)
- Winter Park, Florida (2)
- Round Rock, Texas (2)
- Decatur, Georgia (2)
- Tampa, Florida (2)
- New York, New York (2)
- Farmington Hills, Michigan (2)
- Cordova, Tennessee (2)
- Englewood, Colorado (2)
General eligibility criteria for these studies typically require participants to be between 40 and 85 years of age, regardless of gender. These trials are not open to healthy volunteers or children, focusing specifically on individuals living with the conditions being studied.
Development Timeline
The journey of buntanetap/Posiphen began on May 3, 2022, when the first clinical trial was initiated by Annovis Bio Inc. This marked the start of a comprehensive research program to explore the therapeutic potential of this compound. Initially, the development focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, demonstrating an early interest in diverse medical needs.
As research progressed, the focus expanded significantly into neurological disorders. Annovis Bio Inc. has since broadened its pipeline to include studies for Early Alzheimer's Disease and Parkinson's Disease (PD), including Idiopathic Parkinson's Disease. To date, a total of 4 clinical trials have been conducted or are ongoing, with an impressive cumulative enrollment target of 2,134 participants.
These trials have advanced through various stages of development, including both Phase 2/3 and Phase 3 studies, indicating a progression towards late-stage clinical evaluation. The latest trial is projected to conclude by December 16, 2025, reflecting Annovis Bio Inc.'s continued commitment to bringing buntanetap/Posiphen through rigorous testing.