Monday, May 01, 2017 7:07:03 PM
Not for folks who understand the science. It was an exploratory trial just as the 2a trial was. They want to know the boundaries of this drug, whether it be dosing or length of trial as to determine minimum amount of time required to gain efficacy or frequency of dosing, etc because they know the drug works and want to move it along. What Alkon was firm on is that what they are seeing is now predictable and able to be transferred from animals to humans. They have a handle on the PKCe cycle and can make small adjustments to tweak minor side effects and efficacy. They also plan to run an additional 2 month dosing trial parallel with the open label extension...all of which will narrow down phase 3 parameters and protocol to improve p-value which was just outside tolerance.
The coming data will also show if the SIB scores improved even more than the +1.5 earlier than 12 weeks so they could continue with more frequent dosing or more spaced out dosing (big reason for the dosing study)or if it was still climbing at week 12 which could lead to further improvement in scores as the synapses are continuing to regrow. The data charts will go out to week 17 so the graphs will be really interesting and important moving ahead. Also as the data comes out it will be important to see how patients who were NOT on any memory drugs scored vs those on each of the other individual drugs. Obviously the stage of decline those patients are in on the charts is very important to the SIB scoring vs placebo. Mad scientist is the last thing I heard. He sounded like someone who is extremely excited as they advance the MOA in humans that he studied in animals for years. This was the first widespread proof of that transfer to humans.
I thought CEO Wilkes' comments on BP partnerships were enlightening as she pointed out that with all the plaque failures, companies want to de-risk their porfolios by adding new MOAs and mentioned with all the extensive research with bryostatin, it would make it more valued compared to newcomers. I think any amount of the company we would give up to BP would be worth it to get things moving ASAP.
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