Neurotrope has completed dosing in its Phase IIa clinical trial of Bryostatin-1, a potent modulator of the enzyme protein kinase C epsilon (PKCe), to treat patients with Alzheimer’s disease (AD).
Commenced in late July, the Phase IIa trial is being carried out under an investigational new drug (IND) application filed by the company’s licensor, the Blanchette Rockefeller Neuroscience Institute (BRNI).
In preclinical in vivo models, Bryostatin has been shown to play a major role in slowing or reversing AD and restoring cognition, memory and motor skills.
The trial’s primary objective is to evaluate the safety and tolerability of a single dose of Bryostatin-1, while the secondary objectives include the preliminary evaluation of efficacy using a variety of clinical measures, including an assessment of improvements in cognition.
Final results from the Phase IIa clinical trial of Bryostatin-1 will be reported in January 2015.
Neurotrope chief executive officer and president Charles Ramat said: "Dosing of the last patient in this Phase IIa study marks an important milestone for patients with Alzheimer’s disease and our company.
"Given the millions of patients and families affected by this debilitating condition and the overwhelming need for new, novel therapies that may be able to arrest the progression of the disease, we are as committed as ever to pushing forward with the development of Bryostatin-1."
Currently, the company is developing a randomised, double-blind placebo controlled, multiple-dose clinical trial to further evaluate the efficacy and safety of Bryostatin-1 in the treatment of AD.
Bryostatin is a natural product produced by a marine invertebrate organism, Bugula neritina.