The global trials are completed
https://clinicaltrials.gov/study/NCT04979806?intr=Zidebactam&rank=2
The first cut summary of the trials has come from the company today
It says wck 5222 has demonstrated superiority vs meropenem in the global trials as well. In the India study as well it had 97% efficacy (96.7% in global trials) in meropenem resistance trials.
Out of the 530 patients, since this is a 2:1 trial, 353 patients would have been on WCK 5222 and 177 on Meropenem. Of these 342 patients out of 353 on WCK 5222 have had a clinical cure (no symptoms) while 314 should have had a clinical and microbiolocal cure (no bugs in test post treatment) thus giving a figure of 97% (clinical) and 89% (composite cure i.e. clinical and microbiological). In comparison meropenen composite cure is at just 68.4% - this shows superiorty of WCK 5222 over Meropenem.
This paves the way for filing the NDA in the coming months. This is a big milestone update and a culmination of several years of work and one we have all been waiting for.
To compare odds of an approval, the most recent comparable drug that got approved is Avycaz. The trial results are here.
Avycaz was 0.2% inferior to Meropenem (Both had ~94% efficacy) back then. Notice that Avycaz was concluded “non-inferior” to meropenem. Also this trial “Microbiological confirmation was not a prerequisite” so they did not even do the microbiological test. In WCK 5222’s case, not only is meropenem much worse now (68.4% composite cure) but WCK 5222 is superior instead of Avycaz’s non-inferiority. I think the odds of approval once NDA is filed is pretty high.
Disc: Invested