SUZHOU, China, Oct. 4, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced today that on October 1 its phase III clinical trial of proxalutamide for the treatment of hospitalized COVID-19 patients has enrolled and dosed its first patient in the United States. Proxalutamide is the only small-molecule oral drug which has entered the phase III MRCT clinical trial for treating hospitalized COVID-19 patients.
The U.S. phase III trial is a randomized, double-blind, placebo-controlled, multi-regional pivotal trial, designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients. The primary endpoint for the trial is the time to sustained recovery evaluated by Day 30. The secondary endpoint of the trial is 30-day mortality. This pivotal study has been approved by the US FDA, China CDE, Philippines FDA and ANVISA, and is seeking for approval by more regulatory agencies in Europe and Asia.
Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, "I am delighted to share the great news that the phase III MRCT clinical trial of proxalutamide's treating hospitalized COVID-19 patients has finished the first patient enrollment in the US. More than 100 sites in 14 countries participate in this MRCT clinical trial, which has been greenlighted/approved by the US FDA, China CDE, Philippines FDA and Brazilian ANVISA, and we continue to seek for approvals by regulatory agencies in European and Asian countries. This pivotal study has taken reference to the positive data on efficiency and safety profile of proxalutamide's treating hospitalized COVID-19 patients in the IIT study conducted in Brazil earlier this year. Meanwhile, according to our in-house research and collaborations with US and China's scientists, we are excited to find out that proxalutamide, as an AR antagonist and AR degrader, has demonstrationed a clear mechanism of action including down-regulating ACE-2 and TMPRSS2 proteins, upgrading expression of NrF-2 and inhibiting IL-6 and TNF-alpha etc., thus minimize cytokine storms and tissues damage, which indicates proxalutamide as a possible therapy for severe COVID-19 patients. In this way, proxalutamide is well positioned to be an effective drug for COVID-19 patients from early symptoms to hospitalised."
About Proxalutamide (GT0918)
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. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Meanwhile, proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which activates several antioxidative genes and proteins, and reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection.
Kintor Pharma is now conducting two registered phase III multi-regional clinical trials (MRCT) of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America (including Brazil), the European Union, and Asia. Kintor Pharma was granted an emergency use authorization (EUA) for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay.
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.
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