Suzhou Kintor (HK: 9939) will start a Brazil clinical trial of proxalutamide to treat hospitalized COVID-19 patients, following positive results from several investigator-led trials in Brazil. In the studies, proxalutamide reduced the incidence of progression from mild to severe COVID-19 in 100% of male and 90% of female subjects diagnosed with COVID-19. Proxalutamide is an nonsteroidal androgen receptor antagonist currently being tested to treat prostate and breast cancers. It is thought to limit the expression of ACE-2 and TMPRSS2, which reduces the ability of SARS-CoV-2 to bind and enter host cells in the lung.

In the earlier trial, 319 diagnosed subjects were enrolled. Preliminary data showed:

• Hospitalization rate was 0.8% for the proxalutamide arm, compared to 27.0% for the control arm, 
• Use of ventilators was 0% for proxalutamide arm versus 9.0% for the control arm, and
• Percentage of death was 0% for proxalutamide arm versus 2.0% for the control arm. 

The Institutional Review Board of Brazil approved the trial and accepted proxalutamide for accelerated review.

The trial is a double-blinded, randomized, multi-center investigational study of proxalutamide's treatment for hospitalized COVID-19 male and female patients of 18 years old or above. Approximately 588 patients (294 male and 294 female) who meet the eligibility criteria will be enrolled within 48 hours of admission to hospital. The estimated time from screening to the end of the trial for each patient will be 28 days.

Patients will be randomized to proxalutamide or control arms at a ratio of 1:1. Proxalutamide will be orally administered 300mg once daily (QD) for 14 days. Each arm will also receive standard of care as determined by the principal investigator at the site.

Dr. Tong Youzhi, the founder, chairman and CEO of Kintor Pharmaceutical, said, "Based on the results that proxalutamide could alleviate symptoms and has reduced hospitalization risk of 100% for male COVID-19 outpatients and 90% for female COVID-19 outpatients, respectively, we collaborated with our investigator and quickly initiated the clinical study of proxalutamide for the treatment of hospitalized COVID-19 male and female patients."

Founded in 2009, Kintor aims to develop "best-in-class" and "first-in-class" innovative therapies. It focused on androgen receptor (AR) related diseases for cancers with high incidence and unmet needs, including prostate cancer, breast cancer, liver cancer, hair loss and acne. The company is developing five androgen receptor antagonists, an ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as an PD-L1/TGF-β dual-targeting antibody, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research.

See our other articles on Kintor.

Disclosure: none.