Kintor Pharmaceutical has reported encouraging results from the investigator initiated clinical trial of Proxalutamide for treating female Covid-19 patients.
In November, the trial initiated the enrolment of 168 female patients after obtaining promising results from male patients.
Patients were randomised in a 2:1 ratio and given either Proxalutamide plus standard care (Proxalutamide group) or placebo plus standard care (control group).
The number of participants hospitalised with Covid-19 and the ‘COVID-19 Ordinal Outcome Scale’ in 30 days formed the trial’s primary endpoints.
‘COVID-19 Ordinal Outcome Scale’ is an eight-point ordinal scale used by the US National Institute of Allergy and Infection Diseases, like mechanical ventilation usage and death.
Interim analysis conducted on 7 January is based on 60 patients in the Proxalutamide arm and 35 patients in the control arm.
According to the latest data from the trial, the percentage of hospitalisation, ICU admission, and the need for mechanical ventilation and death was at 1.7% versus 17.1%, 0% versus 8.6%, 0% versus 5.7% and 0% versus 2.9% in the Proxalutamide and placebo cohorts, respectively.
Kintor Pharmaceutical noted that the trial is anticipated to complete enrolment in February and conclude data collection by March.
Kintor Pharmaceutical founder, chairman and CEO Dr Tong Youzhi said: “Special thanks to the AndroCo group led by Dr Andy Goren, Dr Flávio Adsuara Cadegiani, Dr John McCoy and Dr Carlos Gustavo Wambier, who are conducting this important investigator-initiated study.
“Although the female group has lower androgen level as compared to the male group, the data showed that Proxalutamide could significantly ameliorate symptoms and prevent hospitalisation for Covid-19 female patients, which paves the way for our Phase III MRCT registrational trial in the near future.”