Market-Moving Exclusives http://www.benzinga.com/views/taxonomy/term/165347 en Neurotrope's Phase 2 Drug To Treat Alzheimer's Doesn't Clear Threshold For Statistical Significance http://www.benzinga.com/general/biotech/17/05/9373332/neurotropes-phase-2-drug-to-treat-alzheimers-doesnt-clear-threshold-fo <p>After hearing <strong>Neurotrope Inc</strong> (NASDAQ: <a class="ticker" href="http://www.benzinga.com/stock/ntrp#NASDAQ">NTRP</a>) would announce results of its Phase 2 study of potential Alzheimer&rsquo;s Disease (AD) treatment <a href="https://www.benzinga.com/general/biotech/17/01/8960221/neurotrope-a-company-you-never-heard-of-might-have-the-biggest-drug-ev">Bryostatin-1</a>, biotech investors have waited with baited breath through the weekend.</p> <p>On Monday, Neurotrope reported positive top-line results from its Phase 2 study of Bryostatin, which met its primary endpoint in patients that completed the full course of treatment, although the results weren&#39;t particularly encouraging.</p> <p>Tested in 147 patients with moderate to severe AD, a population often excluded from clinical trials, Bryostatin was shown to improve outcomes in cognition and ability to handle daily activities.</p> <p>Of the 147 patients initially enrolled, 113 completed the full 13-week course of treatment, and these 113 (dubbed the &ldquo;Completer Population&rdquo;) showed a mean increase on the<a href="http://www.pearsonclinical.co.uk/Psychology/AdultCognitionNeuropsychologyandLanguage/AdultGeneralAbilities/SevereImpairmentBattery(SIB)/SevereImpairmentBattery(SIB).aspx"> Severe Impairment Battery </a>(SIB) test -- the primary efficacy endpoint, measuring cognition in patients with severe dementia -- of 1.5 versus a decrease in the placebo group of -1.1.The desired p-value of this endpoint was set at p&lt;0.1, and results showed a p-value of &lt;0.07.</p> <p>A second set of patients, the<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4509880/"> modified intent-to-treat</a> (mITT) population, didn&#39;t meet the primary endpoint, having not completed the 13-week assessment.</p> <p>The company will hold a conference call at 8:30 a.m. ET to discuss the data, secondary endpoints, the &ldquo;somewhat higher incidence of diarrhea&rdquo; in drug-taking patients versus the placebo, and why only 113 patients out of the initial 147 completed the full course of treatment.</p> <h3> <strong>The Disease</strong></h3> <p>Alzheimer&#39;s is a type of dementia that causes problems with memory, thinking and behavior. While Alzheimer&rsquo;s doesn&#39;t kill a person directly, as the disease progresses bodily and cognitive functions become increasingly difficult or even impossible.</p> <p>For the past 20 years, the preeminent theory driving Alzheimer&rsquo;s treatment research has been the <a href="http://www.businessinsider.com/what-is-the-amyloid-hypothesis-in-alzheimers-disease-2017-2">amyloid hypothesis</a>, which presumes that clearing out beta amyloid deposits and tau tangles in the brain is the way to go about treating the disease. In AD patients, these ...</p><p><a href=http://www.benzinga.com/general/biotech/17/05/9373332/neurotropes-phase-2-drug-to-treat-alzheimers-doesnt-clear-threshold-fo alt=Neurotrope&#039;s Phase 2 Drug To Treat Alzheimer&#039;s Doesn&#039;t Clear Threshold For Statistical Significance>Full story available on Benzinga.com</a></p> Adam Feuerstein Biotech Bryostatin Dr. Susanne Wilke News NTRP Hedge Funds Top Stories Market-Moving Exclusives General NTRP News Biotech Hedge Funds Top Stories Market-Moving Exclusives General Benzinga Mon, 01 May 2017 10:41:26 +0000 Taylor Cox 9373332 at http://www.benzinga.com