Analysis of the GAIN Trial PR data:
Regarding the cognitive tests: The subgroup with (P. gingivalis aka PG) constituted (242/643) 37.6% of all the subjects. The high dose group with PG, showed a 57% slowing of cognitive decline for ADAS-COG11. This is a significant improvement, but did not meet their predicted improvement of 2.5 points. I think they actually attained ~1.71 points of improvement ( approximately 57% of 2 to 4, being ~1.71 points). There was a dose improvement with the high dose over the 40mg dose, but the 40mg dose had a high p-value, emphasizing the need for the higher dose for better efficacy, but also indicating that the lower dose is near the bottom of the useable dose range.
In summary, if any group of people with AD, took COR388, 37.6% of them would see cognition decline of 43% (much better than 100%).
IIRC the high dose gives much better efficacy than the BIIB aducanumab!
There was also an endpoint test using Activities of Daily Living(ADL). This endpoint was also not met. Why? The company rightly raises the issue that many of these questions are affected by the pandemic lockdown. For example, there are questions about travel and shopping.
Surely, the company will raise this issue with the FDA. What will be the outcome?
I dont know if this board is active, but I thought I would pass this along.
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