Neurotrope Announces Corporate Update

8/5/19

Neurotrope, Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today provided an update on clinical and corporate developments, including its ongoing confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD, and announced financial results for the second quarter ended June 30, 2019.

"The promising data from our previous exploratory Phase 2 trial showed significant improvements in Severe Impairment Battery (SIB) scores for patients in the 20µg Bryostatin-1 dose group not on memantine, an NMDA antagonist. These results may indicate a potential reversal of disease progression in patients with moderate to severe AD, suggesting the potential to translate Bryostatin's neurorestorative properties into the clinic. We look forward to reporting top-line data from our confirmatory Phase 2 study during the third quarter of 2019, and to moving bryostatin forward in the clinic," stated Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer.

Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer, stated: "Our confirmatory Phase 2 trial is based on compelling clinical data that was recently published in the Journal of Alzheimer's Disease.1 Bryostatin regulates the NMDA receptor through PKC activation. Thus, the concurrent use of an NMDA antagonist, which inhibits activity at the receptor, may block the beneficial effects of bryostatin a potential eliminated from the current trial design. Moreover, the consistency observed in 94% of those patients not taking memantine further supports our current study and underscores the transformative potential of bryostatin as a treatment for AD."

Dr. Marwan Sabbagh, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health and member of Neurotrope's Scientific Advisory Board, noted: "Bryostatin has a novel mechanism of action, restoring synaptic networks, with some encouraging data published earlier this year. I believe that positive results from the current study would be a significant advancement for patients with moderate to severe Alzheimer's Disease. I look looking forward to seeing the results of the Confirmatory Phase 2 study in the near future."

Clinical Development Highlights

  • On July 15, 2019, Neurotrope concluded data collection in its confirmatory Phase 2 double blind, placebo controlled clinical trial of Bryostatin-1 in the treatment of patients with moderately severe to severe AD who are not currently taking memantine. Previously, on March 13, 2019, the Company announced dosing of the final patient in the study. A total of 108 patients were enrolled into the study, and top-line data is expected during the third quarter of 2019.

Corporate Announcements

  • In early April 2019, Neurotrope appointed Dr. Michael Ciraolo as general counsel and chief operating officer.

Second Quarter 2019 Financial Results (Unaudited)

As of June 30, 2019, the Company had approximately $21.2 million of cash and cash equivalents. The Company estimates that, contingent upon future product development plans, it has sufficient capital to fund operations through at least the next two years.

About Neurotrope

Neurotrope is at the forefront of developing a new approach to combating AD and other neurodegenerative diseases. The Company's world-class science offers the potential to realize a paradigm shift to overcome one of today's most challenging clinical problems — finding a way to slow or even prevent the progression of AD.

In addition to the Company's Phase 2 trial of Bryostatin-1 in advanced AD, Neurotrope has also conducted preclinical studies of Bryostatin-1 as a potential treatment for rare diseases and brain injury, including Fragile X syndrome, multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett syndrome, and traumatic brain injury. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs.

Please visit www.neurotrope.com for further information.

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