Alzheimer’s digest - 2021

Alzheimer’s digest - 2021

Synaptogenix raised $12.5 M and announced Phase 2b Bryostatin-1 clinical trial update

Bryostatin-1 (Protein kinase C (PKC) agonist) – Synaptogenix

  • The net proceeds of the private placement will be used to fund the ongoing development of Bryostatin-1, which is presently in a Phase 2b NIH-sponsored Alzheimer’s study
  • The company to date dosed 43/100 patients in the Phase 2b trial. Seventeen sites are currently live
  • The monitoring of the balance between the placebo group and the drug group has been completed on a blinded basis by an independent review and there have been no imbalances or safety issues referable to Bryostatin-1 reported thus far
  • Trial details: Phase 2 in Moderately Severe Alzheimer’s Disease; N=100; Bryostatin-1 20 ug IV over 45 minutes, 7 doses over first 12 weeks, followed by second identical course of treatment after 30 days of first 7-dose course vs Placebo IV over 45 minutes, 7 doses over first 12 weeks, followed by second identical course of treatment after 30 days of first 7-dose course; Location: US (For full story click here)

Synaptogenix announced $12.5 million financing to support its ongoing Phase 2b Alzheimer’s study

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CI Scientists Commentary:

  • Previous Phase 2 trials with Bryostatin-1 did not result significant improvement over placebo
    • Additional analysis from the first trial showed improvement in primary endpoint in memantine-naïve patients
    • Based on this outcome, second trial was initiated – which again failed to improve primary endpoint. Further analysis on comparing patient’s status after drug intake to baseline, positive signal was observed
    • Synaptogenix confirmed this positive signal in a pre-specified trend analysis and then initiated its third Phase 2 trial in those AD patients with benefit  
  • This troubled past of the drug helped Synaptogenix to identify the right patient population, modify its outcomes of the study forms) and the spread of those already formed

– Dr. Vidhya Solai, CI Scientists

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