CytoDyn (OTCQB:CYDY -1.9%) reports, what it says, are “clinically significant” results from its Phase 2 clinical trial evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms.
The primary endpoint was the proportion of patients showing clinical improvement, as determined by the change in total clinical symptom score (TCSS), at day 14 compared to placebo, the results of which are not reported.
Instead, it announces day 3 results in a subgroup of patients with a TCSS of at least 4. 90% of patients in this group reported improvements compared to 71% in the placebo arm, a separation that is not indicated to be statistically significant.
One secondary endpoint, the change from baseline in National Early Warning Score 2 (NEWS2), which measures seven clinical parameters such as respiration rate and oxygen saturation, was met. At day 14, 50% of treated patients showed improvement compared to 20% in the control group (p=0.0223).
No data are provided on the other 11 secondary endpoints.
No safety signals were observed.
Management will host a conference call tomorrow, August 12, at 4:00 pm ET to discuss the results.
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