The Phase II study will be performed in collaboration with the National Institutes of Health under a $2.7 million grant.
New York-based Neurotrope announced a new long-term trial of Bryostatin-1 for Alzheimer’s disease (AD). The Phase II study will be performed in collaboration with the National Institutes of Health (NIH) under a $2.7 million grant.
In September 2019, Neurotrope announced the confirmatory Phase II trial of Bryostatin-1 in moderate to severe AD, saying it did not achieve statistical significance on the primary endpoint. The primary endpoint was change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score.
On May 18, 2020, Neurotrope and Metuchen Pharmaceuticals announced a deal where the two companies will merge in an all-stock deal that will become Petros Pharmaceuticals. The expectation is that Petros will become a Nasdaq traded company focused on men’s health. The cornerstone product will be Metuchen’s Stendra (avanafil) for erectile dysfunction. The pipeline will include Metuchen’s in-licensed product H-100 for Peyronie’s disease.
Once the deal is closed, Neurotrope’s Bryostatin-1 and all of its existing assets will be spun out into a new, separately traded company, NBI. Neurotrope will retain about $14 million, including the $2.7 million NIH grant.
Along with the Phase II trial, Neurotrope plans to continue investigation the drug for Multiple Sclerosis and Fragile X syndrome.
“The initiation of a new Bryostatin-1 study in AD, and our efforts in advancing a merger with Metuchen, underscore what we believe is a unique opportunity for our investors to participate in two distinct, publicly-listed companies with potentially meaningful value propositions: Petros Pharmaceuticals, Inc. and the spin-out company NBI,” said Charles S. Ryan, Neurotrope’s chief executive officer.
The new Phase II trial is expected to enroll 100 patients. It will evaluate Brystatin-1 in the absence of Namenda for six months, which will include two 11-week dosing cycles. The study will concentrate on AD patients with pre-specified moderately severe and moderate disease, including a group that showed the most benefit in the previous study. It will plan to assess sustained cognitive benefit as measured by the Severe Impairment Battery (SIB) score.
Namenda (nemantine) is used to treat moderate to severe dementia related to AD. It is marketed by Allergan.
Analysis of the study data will be performed in consultation with Richard Thompson, senior scientist from the Bloomberg School of Public Health at Johns Hopkins University.
“We are hopeful that this trial can substantiate certain compelling data with Bryostatin from previous trials, which suggests patients could potentially see improvement in their disease which, I believe, would be transformative as an AD treatment,” said George Perry, professor of Biology and Chemistry, Semmes Distinguished University Chair in Neurobiology, University of Texas at San Antonio and editor-in-chief of the Journal of Alzheimer’s Disease. “When I see this in the context of currently available drugs, I believe Bryostatin could chart a new path in how we treat Alzheimer’s disease.”
In the previously mentioned study, Brystostatin-1 (20 mcg) was well tolerated and showed early signals of cognitive improvement, including a 5.0 improvement in SIB score compared to baseline in the Moderate Stratum cohort in the non-Namenda group. This score was sustained through the entire treatment period and for four weeks after completion of the study. A second pilot study used the same treatment protocol without for Namenda for 11 weeks showed similar SIB improvement compared to baseline for the Moderate Stratum cohort.
