Chinese company Kintor Pharmaceutical has reported that preliminary analysis data from an investigator-initiated trial (IIT) of its Proxalutamide for treating Covid-19 showed the trial met both of the co-primary efficacy endpoints.
A novel androgen receptor (AR) antagonist, Proxalutamide is currently in Phase I-III clinical trials in China and the US for treating prostate and breast cancer.
Proxalutamide could limit the expression of ACE-2 and TMPRSS2, which play a major role in SARS-CoV-2 binding and entering host cells in the lungs, Kintor has found.
The randomised, double-blind and placebo-controlled clinical trial is analysing the role of the anti-androgen agent for treating Covid-19. The preliminary analysis of the trial enrolled 319 participants.
The number of patients hospitalised with Covid-19 and the Covid-19 Ordinal Outcome Scale in 30 days are the trial’s co-primary endpoints.
Data showed that in the Proxalutamide arm, the hospitalisation rate was 0.8% versus 27% in the control arm.
In the treatment arm, no mechanical ventilation usage or death was observed as compared to 9% and 2% respectively in the control arm.
Kintor Pharmaceutical founder, chairman and CEO Dr Tong Youzhi said: “Proxalutamide, as an AR antagonist, is used for the treatment of tumour and AR-related non-tumour diseases.
“We are glad to see the positive results in Covid-19 clinical trials with Proxalutamide, which is expected to reduce the probability of the progression from mild to severe in Covid-19 patients by lowering the expression of TMPRSS2 and ACE-2 proteins.”
“We are actively initiating MRCT Phase III clinical trials in countries such as the US and China, and hope to obtain an emergency use authorisation (EUA), in this way more Covid-19 patients would benefit from Proxalutamide.”
The final clinical study results from the clinical trial are expected in January next year.