Synaptogenix has concluded subject enrolment in the Phase IIb clinical trial of its lead therapeutic candidate, Bryostatin-1, to treat patients with advanced and moderately severe Alzheimer’s disease (AD).
A total of 100 subjects were enrolled in the ongoing trial, which is sponsored by the US National Institutes of Health (NIH).
The trial’s independent Data Safety Monitoring Board (DSMB) has confirmed that no drug-associated adverse safety concerns were reported.
Topline results from the trial are anticipated during the fourth quarter of this year.
Patients treated with Bryostatin-1 had substantial cognitive enhancement in the absence of Namenda in two previous consolidated three-month pilot trials while subjects in the placebo arm showed no substantial benefit.
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The present six-month, placebo-controlled trial will have Bryostatin-1 treatment with double the number of doses and randomised enrolment to be controlled for balanced baselines in the treatment and placebo arms.
As the benefit was priorly seen to last a minimum of 30 days post-dosing, subjects will have been monitored for three months after discontinuing the treatment.
Synaptogenix president and chief scientific officer Daniel Alkon said: “The absence of any drug-related adverse events, as have been observed with the few other therapeutic strategies reaching limited Food and Drug Administration (FDA) approval for AD, should facilitate our subsequent steps toward clinical utility.
“Benefits of at least 4.0 SIB scores, above baseline, are likely to be clinically meaningful, and therefore have the potential to treat the underlying disease as well as to provide symptomatic relief.”
Bryostatin-1 showed regenerative mechanisms of action for the rare disease, Fragile X syndrome and other neurodegenerative ailments such as multiple sclerosis, stroke and traumatic brain injury in preclinical studies.
Earlier, it received Orphan Drug Designation from the US FDA to treat Fragile X syndrome.
