Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bryostatin · 2 trials · 1 indication
Treatment emergent adverse events and serious adverse events will be analyzed by treatment group.
The treatment difference in the primary efficacy endpoint of Severe Impairment Battery (SIB). The SIB is used to assess cognition in subjects with moderate and severe AD. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.
Incidence of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
The Severe Impairment Battery (SIB) assesses cognition in subjects with moderate and severe Alzheimer's disease(AD). Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
| Arm | Type | Description |
|---|---|---|
| Bryostatin 1 | ACTIVE_COMPARATOR | 20ug Bryostatin will be administered over 45 minutes IV. The course of treatment will include 7 doses over the first 12 weeks, followed by a second identical treatment period beginning 30 days after completion of the first treatment period. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered over 45 minutes IV. The course of treatment will include 7 doses over the first 12 weeks, followed by a second identical treatment period beginning 30 days after completion of the first treatment period. |
| Bryostatin 20µg | EXPERIMENTAL | 20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Bryostatin 1 | DRUG | Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course. |
| Placebo | OTHER | Placebo administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course. |
| Bryostatin | DRUG | The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. |
Inclusion Criteria: 1. Written informed consent from caregiver and subject (if possible) or legally acceptable representative if different from caregiver 2. Male and female subjects 55-85 years of age inclusive 3. Cognitive deficit present for at least 2 years that meet the diagnostic criteria for ...
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Bryostatin is an investigational small molecule being developed for the treatment of Alzheimer's Disease, specifically moderately severe to severe forms of the condition. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Bryostatin is being developed by Petros Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol PTPI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's Disease.
Bryostatin is in Phase 2 clinical development for the treatment of Alzheimer's Disease. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness.
Bryostatin has been studied in three completed Phase 2 clinical trials in the United States: NCT02431468, NCT03560245, and NCT04538066. These trials enrolled a total of 377 patients with moderately severe to severe Alzheimer's Disease, with participants aged 55 years and older.
Bryostatin is a small molecule that modulates protein kinase C (PKC) activity, an enzyme involved in various cellular signaling pathways. By activating PKC, it is thought to enhance synaptic function and promote neuronal survival, which may be beneficial in treating Alzheimer's Disease.