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(Reuters) – China’s Kintor Pharmaceutical Ltd said data from a Phase III clinical trial for its potential COVID-19 treatment proxalutamide in non-hospitalised patients did not meet statistical criteria in the interim analysis due to the low number of hospitalisations.
“In a trial that had enrolled 384 people for interim analysis, a limited number of participants whose illness progressed from mild or moderate symptoms to the degree that required hospitalization was reported,” a Kintor representative said on Monday.
The low number resulted in the lack of statistical significance in data analysis between placebo group and the group where participants took the proxalutamide tablet, the representative said, without disclosing detailed readings.
Kintor said in a filing on Monday that it will seek consent from authorities, including U.S. Food and Drug Administration, to amend clinical protocol and continue to enroll patients of higher risk, such as those who have not received a COVID-19 vaccination.
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