Neurotrope Inc (OTCMKTS:NTRP): Here's What We're Looking For From The Upcoming Data

Neurotrope Inc (OTCMKTS:NTRP) took a real hit earlier this month on the back of a private placement that saw it issue shares at a deep discount to market, and the company has failed to recover any substantial portion of the lost market cap since. The company has just reshuffled its management tea, however, and set to release data from a phase II trial in Alzheimer's relatively near term.Does the combination of a fresh injection of capital (albeit at shareholders' expense), a fresh leadership team and a pending catalyst in one of the holy grails of healthcare have the potential to reverse the trend?Maybe.Neurotrope is developing a drug called bryostatin, and the only real value-add program right now is the above mentioned Alzheimer's target. There are a couple of preclinical programs involving the same asset, one in Fragile X Syndrome and one in Niemann-Pick Type C, but these are preclinical, so we're not attributing any major valuation impact to these as things stand.The upcoming trial is targeting Alzheimer's in moderate to severe patients, and it just completed enrollment of 148 patients. The drug under investigation is a pretty interesting one. It dates back to the 1960s, and has since been used as an investigational target in cancer, AIDS/HIV and – as is the case here – Alzheimer's. In this latter indication, it acts as an activator of an enzyme called protein kinase C (PKC). This activation (theoretically) can help lead to the rebuilding of the synaptic networks that are associated with the neurodegenerative impact of Alzheimer's, and in turn, could potentially halt the progression of, or even reverse the effects of, the disease.It's a nice theory, but it's very tough to prove in the clinic. Alzeheimer's has had a huge number of high profile flops over the years, with the most recent being Eli Lilly and Co (NYSE:LLY)'s Solanezumab, and to say that Neurotrope faces an uphill battle in getting this one in front of the FDA by way of an NDA submission is an understatement.With that said, data to date (and this includes legacy ex vivo and animal model data, as well as early stage clinical studies conducted by Neurotrope) look promising. With the size of the potential market as large as it is, the reward is certainly there if the company can achieve what – as yet – others have failed to.So what are we looking for going forward as reinforcing a bullish thesis?The company's phase II trial kicked off last year, and primary completion is slated January 2017. Data won't be released until the second quarter, however, so that's our focus time frame. The trial is double blinded, comparing the drug to placebo, so we're looking at a stat sig difference in improvement across the primary endpoint measures, and as a kicker, some similar improvement across a host of secondaries.Co-primaries are safety (which is obviously important, but it's not going to be the value driver) and efficacy, as measure by a change in what's called the Severe Impairment Battery (SIB). SIB is the gold standard, benchmark assessment tool used in this indication, and combined with the fact that Neurotrope is going after severe cases, this is a brave primary. If it hits, of course, it could pay off big. Secondaries include the Mini Mental State Exam (MMSE), Activity of Daily Living (ADL) and Neuropsychiatric Inventory scale (NPI).Just how long the capital raised is going to last remains to be seen/reported, and that’s the risk on this one. If the company can hit on its efficacy points, there's every chance it will need to raise again ahead of a phase III initiation. That said, a hit would likely mitigate any dilution in terms of market cap gains.We will be updating our subscribers as soon as we know more. For the latest updates on NTRP, sign up below!Disclosure: We have no position in NTRP and have not been compensated for this article.