China's Kintor says interim analysis of COVID treatment trial misses statistical criteria (updated)

Kintor Pharmaceutical

27/12/2021 13:14

(Adds comment from a Kintor representative)
    BEIJING, Dec 27 (Reuters) - China's Kintor Pharmaceutical
Ltd  9939.HK  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.
    

 (Reporting by Roxanne Liu and Ryan Woo; Editing by Kirsten
Donovan and Louise Heavens)
 ((meg.shen@thomsonreuters.com; 852-39525805;))