Neurotrope (NTRP) will release its Bryostatin Phase 2b top line data this week (company’s guidance). The primary efficacy endpoint is based on Severe Impairment Battery Scale (SIB). Entry criteria was based on the MMSE score. Secondary efficacy endpoints were based on – Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI), and Mini-Mental State Exam (MMSE).
Considering 70% of all phase two drug trials fail, and even more so with Alzheimer’s Disease (AD) indications, this will be a cage fighting, raw, win or lose, zero or hero event.
We are long NTRP and we wrote about our thesis right here. We are comfortable with our position given our utility curve, our assessment of the situation, its risk and reward potential.
We have the utmost respect for investors going into the event with a short or long position based on their assessment. This is not easy; it shows conviction with a position under imperfect information.
Given the history of AD trials results, it is understandable that many label this situation as a failure from the get go. To be clear, we are handicapping the probability of success and its associated payoff much differently.
ProMIS Neurosciences (PMN.TO) is conducting a cohort study to demonstrate the prevalence of 5 strains (5 epitopes) of soluble toxic oligomers in the cerebrospinal fluid (CSF) of 100 cadavers at the University of British Columbia of patients who had been diagnosed with AD. The results of this study could confirm and present a profile of heterogeneity in AD patients. Based on these results, ProMIS monoclonal antibodies (5 mabs) could be used to create CSF diagnostics for early detection in patients at high risk of the disease.
These mabs could also be used by researchers to advance AD’s science turning PMN’s IPs and therapeutics portfolio into a platform.
The cohort study results should readout before the end of May (our expectation).
In addition, PMN is running blood based screening assays to detect these toxic oligomer strains at the molecular level (5 epitopes). If PMN can overcome the challenges posed by the hypothesis that toxic oligomers have a very short half-life in blood, the company could be in a position to provide a data readout this summer or fall.
We are long ProMIS Neurosciences and we wrote extensively about it here.
Disclaimer: We are long the securities and some of their associated derivatives. The likely outcome of an investment in early stage biotech companies is a loss of principal. Take our opinions with a grain of salt. If you find yourself relying on our views to make an investment decision it means you definitely did not do your homework about these situations. Please do not rely on our views, instead use the information as a jumping off point to begin your own independent due diligence.