Tuesday, July 21, 2020 5:59:16 PM
Leronlimab in COVID: Sixty percent reductions in Severe Adverse Event ("SAE") safety metrics in controlled trial. Efficacy data upcoming.
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In an 86-patient randomized controlled trial, leromlimab reduced the percentage of patients with SAEs by 58.4% and the total number of SAEs per patient by 63.8%. Considering any level of adverse event, leronlimab decreased patients impacted by 32.2%.
The percentage of leronlimab patients with SAEs was 8.9%, versus 21.4% in the control arm of the trial. The control arm received "standard of care" treatment, which typically included multiple other drugs.
Because the definition of Serious Adverse Events includes both disease-caused and drug-caused events, they provide possible insight into the more detailed clinical efficacy findings that will be released as available. No drug-caused SAEs were recorded among leronlimab users.
Raw numbers are as follows:
Totals.-----------------.Leronlimab.---.Control
Number of patients.--------- 56 --------- 28
# patients with SAEs.------- 05 --------- 06
Total SAEs.------------------- 08 --------- 11
# patients, any AE.--------- 19 --------- 14
Per patient - - - - - - - Leronlimab - - Control - -Relative Risk
% patients with SAEs - - - - 8.9% - - - - 21.4% - - - -58.4%
Total SAEs per patient - - - .142 - - - - .392 - - - - -63.8%
% patients with any AE - - - 33.9% - - - 50.0% - - - - -32.2%
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