Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection (NCT04870606). 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 COVID-19 patients. At the interim analysis, 348 patients with mild-to-moderate COVID-19 symptoms were enrolled. Kintor Pharma will seek for Health Authorities including the U.S. Food & Drug Administration's consent to amend the protocol and continue to enroll higher risk COVID-19 patients only with multiple comorbidities and/or patients with no COVID-19 vaccination history. Based on the interim analysis, there were no safety concerns and no drug-related serious adverse events (SAEs) reported during the study.
As of December 23, 2021, Kintor Pharma had completed the enrollment of this pivotal study according to the original protocol. More than 95 percent of the enrolled patients were from the U.S. For the interim analysis, all patients were from the U.S., where the hospitalization rate is very low.
Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma commented, "The COVID-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics. It is important to investigate new modalities to treat those infected with the virus. We believe proxalutamide could become an important tool in the fight against COVID-19 infection and will continue to investigate its use. We will provide updates on the final data analysis from this outpatient clinical trial in due course."
The outpatient study is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of proxalutamide in outpatients with mild to moderate COVID-19 illness. For the interim analysis, the trial enrolled 348 male and female patients with one or more mild COVID-19-related symptoms within five days of symptoms onset. Participants were randomized to receive proxalutamide (200 mg) or placebo orally twice daily for 14 days. The enrolment covers the whole population including patients with a vaccination history, as well as without any risk factors. Both the treatment arm and placebo arm were given standard of care. The primary endpoint was the percentage of all-cause death and hospitalization for a period exceeding 24 hours by day 28.
About Kintor's Multi-Regional Clinical Trials for Proxalutamide
Kintor Pharma is conducting two registered Phase III multi-regional clinical trials (MRCT) of proxalutamide for the treatment of COVID-19 outpatients, and one Phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America (including Brazil), Asia (including China) and the European Union.
The second outpatient study (NCT04869228) plans to enroll 724 patients, with the primary endpoint of percentage of subjects requiring oxygen by day 28. The inpatient study (NCT05009732) is a randomized, double-blind, placebo-controlled Phase III study. Male and non-pregnant female hospitalized adults are included. The primary endpoint is time to sustained recovery, and the key secondary endpoint is percentage of all-cause mortality.
Kintor Pharma was granted an emergency use authorization (EUA) for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay.
About Proxalutamide
Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Proxalutamide promotes the clearance of...
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