Suzhou's Kintor Pharma (HK: 9939) reported the US FDA approved a Phase III trial of proxalutamide as a treatment for male COVID-19 outpatients. Proxalutamide is Kintor's novel androgen receptor (AR) antagonist that is currently being tested as a prostate and breast cancer therapy in Phase I-III trials in China and the US. Kintor says proxalutamide may limit the expression of ACE-2 and TMPRSS2, which plays a role in allowing SARS-CoV-2 to bind and enter host cells in the lung. In a clinical trial, proxalutamide significantly lowered the SARS viral load over the control.

Kintor pointed out it is the first China-based biopharma whose small-molecule novel drug was approved to start a Phase III clinical trial by the FDA to treat COVID-19.

Founded in 2009, Kintor develops "best-in-class" and "first-in-class" novel therapies for androgen receptor (AR) related diseases. Its candidates address prostate cancer, breast cancer, liver cancer, hair loss and acne. The company's pipeline includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as a PD-L1/TGF-β dual-targeting antibody, an AR-Degrader and c-Myc inhibitors.

Dr. Youzhi Tong, Founder, Chairman and CEO of Kintor Pharmaceutical, said, "We are delighted to receive this Phase III clinical trial approval from the FDA. According to the existing clinical data, the efficacy and safety profiles of Proxalutamide in the treatment of patients with COVID-19 are outstanding. We strive to launch Proxalutamide to the market for COVID-19 treatment as soon as possible."

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Disclosure: none.