China’s Kintor Pharma officially released on Wednesday the key data results of the phase III clinical trials on the treatment of non-hospitalized patients with mild to moderate symptoms of COVID-19. The data show that its oral medicine, Proxalutamide, reduces the risk of hospitalization or death especially in those with high-risk factors and demonstrates significant reduction in COVID-19 viral load and improved coronavirus-related symptoms.
Proxalutamide is a new generation of androgen receptor antagonist, which is a novel coronavirus oral drug.
On December 27, 2021, Kintor Pharma provided an update on its multi-regional study of Proxalutamide for the treatment of COVID-19 infections and said the statistical criteria were not met at an interim analysis of the phase III outpatient study, designed for testing efficacy and safety of Proxalutamide for treating COVID-19 in non-hospitalized patients. At the interim analysis, 348 patients with mild-to-moderate symptoms were enrolled.
According to Kintor Pharma, Proxalutamide effectively reduced the risk of hospitalization or death. Among all randomized patients with at least one day of treatment (N=730), 8 patients who received placebo were hospitalized (including one death) compared to 4 patients who received proxalutamide (zero death). All hospitalizations were COVID-19-related. Proxalutamide reduced the risk of hospitalization or death by 50 percent compared to the control group.
Kintor Pharma also said that Proxalutamide significantly reduced the risk of hospitalization/death in patients with high-risk factors, especially in patients 50 years of age or older and with at least one day of treatment. In patients aged 50 years or above and with obesity, Proxalutamide significantly reduced the risk of hospitalization or death by 100 percent (p﹤0.02), as there was no hospitalization or death in the Proxalutamide group.
The report also said that COVID-19 symptoms such as fever, shortness of breath and cough were improved through Day 28 compared with patients in the control group.
About the safety of the drug, Kintor Pharma announced that the study demonstrated that Proxalutamide was well tolerated and its side effects were manageable among patients. The incidence of treatment emergent adverse events (TEAEs) was comparable in the control and Proxalutamide groups (7.9 percent and 9.6 percent, respectively). The majority of TEAEs were mild. The most common adverse event was dizziness (1.1 percent in both Proxalutamide and control groups). The incidence of any other adverse events was less than 1 percent and there was no serious adverse event in the study.
Photo: Courtesy of Kintor Pharma
