Kintor Pharma (HK: 9939) of Suzhou started a global Phase III trial of proxalutamide in hospitalized COVID-19 patients. Kintor said its candidate is the only small-molecule oral drug that has started a Phase III MRCT trial for hospitalized COVID-19 patients. The primary endpoint for the trial is the time to sustained recovery evaluated by Day 30, with a secondary endpoint of 30-day mortality. The pivotal study has been approved by the US FDA, China CDE, Philippines FDA and ANVISA, and it is seeking for approval by more regulatory agencies in Europe and Asia.

Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development to treat COVID-19, prostate cancer, and breast cancer. Proxalutamide has the potential to inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2.

In addition, proxalutamide is thought to promote the clearance of pathogens and decrease 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 is currently also conducting two registered Phase III multi-regional clinical trials of proxalutamide to treat COVID-19 outpatients, along with the global MRCT for COVID-19 inpatients. In Paraguay, Kintor was granted emergency use authorization (EUA) for proxalutamide in hospitalized COVID-19 patients.

According to Kintor's in-house research and collaborations with US/China scientists, proxalutamide, as an AR antagonist and AR degrader, has a clear mechanism of action. It down-regulates ACE-2 and TMPRSS2 proteins, upgrades expression of NrF-2 and inhibits IL-6 and TNF-alpha. This minimizes cytokine storms and tissue damage.

Dr. Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, said, "I am delighted to share the great news that the Phase III MRCT clinical trial of proxalutamide has been dosed to the first hospitalized COVID-19 patient in The US. More than 100 sites in 14 countries participate in this MRCT clinical trial. 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 in patients from early symptoms to hospitalized."

Kintor develops 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.

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Disclosure: none.