Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced an update on its ongoing National Institutes of Health ("NIH") sponsored Phase 2b clinical trial of Bryostatin-1 in patients suffering from moderately severe Alzheimer's disease ("AD"). To date, the Company has now dosed 58 of its target 100 patients. Seventeen sites continue to be live.
Additionally, the independent Data Safety Monitoring Board ("DSMB") overseeing the trial convened to assess the safety of Bryostatin through an interim analysis and confirmed that 40 advanced AD patients have been dosed with Bryostatin without any significant safety issues.
Alan Tuchman M.D., Chief Executive Officer, stated, "With the spotlight firmly on Alzheimer's disease following the recent FDA approval of Aducanumab, we are encouraged to see the level of evidence for Bryostatin-1 continues to grow. The DSMB assessment further validates the significant safety profile of Bryostatin, as opposed to safety issues observed with other candidate Alzheimer's drugs now being developed."
"Our two previous pilot trials demonstrated safety while also showing a 4.8 improvement over baseline of the Severe Impairment Battery Score. We are pleased that our ongoing six-month Phase 2b trial sponsored by the NIH, has also displayed signs of safety thus far, consistent with our two previous trials," stated Dr. Daniel Alkon, President and Chief Scientific Officer. "Efficacy and safety continue to be our primary objectives in the clinical trials of Bryostatin to treat advanced AD patients."
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