Notes from today’s conference call at CytoDyn (OTCQB:CYDY) regarding the results from a Phase 2 clinical trial evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms.
Company has applied for emergency use of the drug to treat these patients in the U.S.
CEO emphasizing the NEWS2 secondary endpoint which was met, not the primary endpoint which was missed.
Phase 2 was a proof-of-concept study that informed the design of the Phase 3. NEWS2 to be the primary endpoint of the latter.
The advantage of NEWS2 is the reliance on objective parameters instead of patient-reported symptoms that comprised the Phase 2 primary objective.
Premature to know if the ongoing Phase 2 in severely and critically ill COVID-19 patients will be a “single, double, triple or home run.” An interim analysis will be conducted after 195 patients have been treated.
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