Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the phase III clinical trial of proxalutamide for the treatment of male patients with mild or moderate COVID-19 symptoms in the United States has completed the first patient enrollment and dosing.
Dr. Xunwei Dong, Chief Medical Officer of Kintor Pharmaceutical, commented, “Initiation of this phase III study of proxalutamide in male with mild or moderate COVID-19 symptoms in the U.S. and other countries is a key milestone in fulfilling our mission to discover and develop effective therapies for COVID-19. We have been actively initiating MRCT phase III trials in the U.S., the EU, South Africa and South America including Brazil. We will keep close communications with the U.S. FDA and other local regulatory authorities, and complete this pivotal study with high quality and efficiency.”
About the Study
The phase III trial is a randomized, double-blind, placebo-controlled, multi-regional pivotal trial, designed to evaluate the efficacy and safety of proxalutamide in male outpatients with mild or moderate COVID-19 symptoms. The primary endpoint for the trial is the percentage of hospitalization events (including death) by Day 28. The secondary endpoints of the trial include but not limited to proportion of mortality by Day 28, percentage of patients achieving each clinical status on Days 7, 14 and 28 using National Institute of Allergy and InfectiousDiseases (NIAID) 8-point scoring scale.
About Proxalutamide (GT-0918)
Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer.
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne. For more information, visit www.kintor.com.cn