Jun. 25 at 7:42 AM
$CNTB So, some clear Perspective on this new horizon of unmet need w this SEABREEZE trial.
What we know,
Rademikibart in previous trials focused on maintenance therapy & posted up better FEV1 #s (Lung function) than Dupixent.
In those trials came a realization.
It was extremely fast acting & the patients w a high eosinophil count 300> (acute exacerbation) the FEV1 gain was +420 ML vs placebo, some of the highest gain ever recorded by a biologic.
And a brand new indication was born for acute patients w no true options in ER.
The SEABREEZE trial,
Changing delivery to an IV Push w 300mg in ER for acute exacerbation patients w 300> eosinophil & the Primary Endpoint of failure rate @ 28 days. (FEV1 & Safety also major endpoints)
This Trial design & need in real world is in Rademikibart wheelhouse.
Having the DMC already look @ this trial w a magnifying glass & rightly so because it is ER setting of acute patient pop, safety hurdle cleared.
