Clinical-stage biopharmaceutical company Neurotrope Inc. (NTRP:NASDAQ), which is focused on developing novel therapies for neurodegenerative diseases, today announced its corporate update pertaining to recent developments at the company.
The company indicated that it has completed the analysis of the data from its recently reported Phase 2 confirmatory clinical ("203 study") trial, which is examining moderately severe to severe Alzheimer's disease patients treated with Byrostatin-1 in the absence of memantine/Namenda.
In reference to the 203 study, the company's President and Chief Scientific Officer Dr. Daniel Alkon commented, "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...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)."
Kazem Kazempour, CEO of Amarex Inc., the biostatistician retained to analyze the data from the 203 study under the SAP added, "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...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."
The firm additionally reported that "it was awarded a $2.7 million grant from the National Institutes 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."
Dr. Marwan Sabbagh, director of the Cleveland Clinic Lou Ruvo Center for Brain Health and advisor on the design of the 203 trial, remarked, "I am encouraged by the NIH funding...The data suggests that Bryostatin may still be considered a new approach to Alzheimer's treatment."
Neurotrope is headquartered in New York City and began the day with a market capitalization of around $18.9 million with approximately 13.07 million shares outstanding and a short interest of about 4.1%. NTRP shares opened almost 56% higher today at $2.26 (+$0.8102, +55.88%) over yesterday's $1.4498 closing price. The stock has traded today between $2.25 and $3.85 per share and is currently trading at $3.09 (+$1.64, +113.13%).
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