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ARTICLE | Clinical News

Neurotrope reports mixed Ph III AD data for Bryostatin-1

May 5, 2017 9:02 PM UTC

Neurotrope Inc. (NASDAQ:NTRP) said top-line data from the modified intent-to-treat (mITT) population (n=135) of the double-blind, U.S. Phase II NTRP-101-202 trial to treat moderate to severe Alzheimer’s disease showed that 20 μg IV Bryostatin-1 failed to meet a prespecified one-tailed significance threshold of p<0.1 on the primary endpoint of improving Severe Impairment Battery (SIB) score at week 13 vs. placebo (mean increase of 1.2 points vs. a reduction of 0.8 points, one-tailed p-value of <0.134). In the study's completer population (n=113), the company said the 20 μg dose met the significance threshold for the primary endpoint (mean increase of 1.5 points vs. a reduction of 1.1 points, one-tailed p-value of <0.07).

The trial enrolled 147 patients and also evaluated a 40 μg dose of Bryostatin-1. Neurotrope said the higher dose did not meet the significance threshold in either population, but performed better than placebo...