Neurotrope (NTRP) Provides Corporate Update After Completing Bryostatin-1 Data Analysis for Advanced Alzheimer's Disease Trial

Neurotrope, Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, today announced its corporate update.

The Company has completed analysis of the data (Clinical Study Report) from its recently reported Phase 2 confirmatory clinical trial (the "203 study"), examining moderately severe to severe Alzheimer's disease patients treated with Byrostatin-1 in the absence of memantine / Namenda.

"A significant imbalance (4.8 points) in the baseline Severe Impairment Battery ("SIB") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. "After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan ("SAP")," stated Dr. Alkon.

"Due to the baseline imbalance observed in the study, and because a clear signal of benefit could be observed in the raw data from the pre-specified Moderate Stratum, we conducted a post-hoc analysis using paired data for individual patients, with each patient as his/her own control," stated Kazem Kazempour, Chief Executive Officer of Amarex, Inc., the biostatistician retained to analyze the data from the 203 study under the SAP. For the pre-specified Moderate Stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the Bryostatin-1 treatment group and 33 patients in the placebo group. There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed.

In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. "This smaller, placebo effect could possibly be due to the imbalance observed even for the Moderate Stratum in the study," stated Dr. Alkon. For the pre-specified Severe Stratum (MMSE-2 baseline scores 4 – 9) patients, there was no statistically significant change from baseline for either the treatment or the placebo group.

As a further test of the robustness of this Moderate Stratum benefit signal, a pre-specified trend analysis (measuring increase of SIB improvement as a function of successive drug doses) was performed on the repeated SIB measures over time (Weeks 0, 5, 9, and 13). These trend analyses showed a significant positive slope of improvement for the treatment groups in the 203 study that was significantly greater than for the placebo group (p<.01).

The Company is pleased to announce that it has been awarded $2.7 million from the National Institute of Health ("NIH") to support an additional Phase 2 clinical study focused on the Moderate Stratum for which the Company saw improvement in the 203 study. Neurotrope looks forward to working with the NIH on the continuation of the Bryostatin program. The Company is planning to meet with the Food and Drug Administration to present the totality of the clinical program data for Bryostatin-1 (NTRP101-202 and NTRP101-203).

"I am encouraged by the NIH funding," stated Dr. Marwan Sabbagh, Director, Cleveland Clinic Lou Ruvo Center for Brain Health, and advisor on the design of the 203 trial. "The data suggests that Bryostatin may still be considered a new approach to Alzheimer's treatment." Dr. Sabbagh is also a paid member of the Company's Scientific Advisory Board.

Neurotrope continues to review several viable strategic alternatives. "We are continuing our efforts to identify the most favorable strategic alternative for the Company," stated Charles S. Ryan, Neurotrope's Chief Executive Officer. "The Committee has been working tirelessly in an effort to increase shareholder value. We are pleased with the progress that has been made and expect to provide additional guidance in the near future."

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