Another investigational drug trial for the treatment of Alzheimer’s is set to release key findings within the next few months. Neurotrope, Inc. recently announced the closure of their Phase 2a clinical trial of Bryostatin-1, as the last patient enrolled in the study was administered the drug. The trial was conducted under an Investigational New Drug (IND) application.
The Phase 2a clinical trial’s primary objective is to determine Bryostatin-1’s single-dose safety and tolerability, while also determining its efficacy in treating Alzheimer’s disease as measured by improvements in cognition. The company announced that the results are expected in January 2015, and that they are currently developing a follow-up multiple-dose clinical trial to further assess the drug’s efficacy and safety in treating Alzheimer’s disease.
Charles S. Ramat, Chief Executive Officer and President of Neurotrope, noted, “Dosing of the last patient in this Phase 2a study marks an important milestone for patients with Alzheimer’s disease and our company.” Paul Freiman, Chairman of the Company, added, “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.”
What is particularly interesting about Bryostatin is that it is produced naturally by a marine invertebrate organism – Bugula neritina — and is retrieved from the ocean after being isolated from other organic materials. Other bryostatin derivatives are being developed in Stanford University that carries an exclusive license for their development as well. This project as well as other variations of the complex represent potential sources for drug supply. For the Alzheimer’s disease patient population, the findings from the current Bryostatin-1 study are highly anticipated, since there are no FDA-approved therapies currently available that halt or repair the neurodegenerative damage caused by the disease — only drugs that moderately curtail its symptoms.