Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bryostatin 1 · 1 trial · 1 indication
Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. 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.
| Arm | Type | Description |
|---|---|---|
| Bryostatin 1 20ug | EXPERIMENTAL | 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. |
| Bryostatin 1 40ug | EXPERIMENTAL | Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Bryostatin 1 | DRUG | The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. |
| Placebo | OTHER | The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution. |
Inclusion Criteria: * Written informed consent from caregiver and subject (if possible) or legally acceptable representative if different from caregiver * Male and female subjects 55-85 years of age inclusive * Cognitive deficit present for at least 2 years that meet the diagnostic criteria for pro...
Top 20 of 24 competitors
Bryostatin is an investigational small molecule being developed for the treatment of Alzheimer's Disease, specifically in patients with 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 currently in Phase 2 clinical development. It has completed three Phase 2 clinical trials in the United States, all of which have been completed. The drug remains investigational and has not received FDA approval for any indication.
Bryostatin has completed three 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 all studies being randomized, double-blind, and placebo-controlled.
Bryostatin is a small molecule that works by modulating protein kinase C (PKC) activity, which is involved in synaptic plasticity and memory formation. By activating PKC, Bryostatin aims to enhance cognitive function in patients with Alzheimer's Disease, though its exact mechanism of action is still under investigation.