Proxalutamide Top-Line Data for COVID-19 Phase III MRCT Study

● Proxalutamide demonstrates a significant reduction in hospitalization/death rate with a protection rate reaching 100% for patients treated more than seven days (p <0.02).

● Proxalutamide reduced risk of hospitalization or death especially in those with high-risk factors.

● Proxalutamide demonstrates significant reduction in COVID-19 viral load and improved coronavirus-related symptoms.

● The Phase III multi-regional clinical trial (MRCT)  enrolled 99% of patients in multiple centers accross the United States.

Suzhou, April 6, 2022, Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced the top-line results of the Phase III MRCT of proxalutamide in outpatients with mild to moderate COVID-19 regardless of vaccination status and risk factors. Data from the study demonstrated that the protection rate of patients in the trial (regardless of age or risk factors) treated with proxalutamide for more than seven days reached 100% (p < 0.02). The treatment with proxalutamide significantly reduced hospitalization or death in COVID-19 patients, especially in the middle-aged and elderly with high-risk factors. 

Top-line efficacy and safety data are summarized below:

Efficacy: 

Proxalutamide effectively reduced the risk of hospitalization/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% compared to the control group.

●Among patients with more than 1 day of treatment (N=721), 7 patients in the control group were hospitalized (including one death) compared to 2 patients (zero deaths) in the proxalutamide group. Proxalutamide reduced the risk of hospitalization or death by 71% compared to the control group.

●Among patients with more than 7 days of treatment (N=693), 6 patients who received placebo were hospitalized (including one death) compared to no hospitalization/death in the proxalutamide group. Proxalutamide reduced the risk of hospitalization or death by 100% compared to the control group (p﹤0.02).

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 1 day of treatment.

● In the patients aged 50  years or older and with obesity, proxalutamide significantly reduced the risk of hospitalization/death by100% (p﹤0.02), as there was no hospitalization or death in the proxalutamide group.

● In the patients aged 60 years or older with or without underlying medical conditions, proxalutamide significantly reduced the risk of hospitalization or death by 100% (p﹤0.02), as there was no hospitalization or deaths in the proxalutamide group.

● In the patients with age 60 years or older and with at least one underlying medical condition (such as obesity, diabetes, hypertension, etc.), proxalutamide significantly reduced the risk of hospitalization or death by 100% (p﹤0.02), as there was no hospitalization or deaths in the proxalutamide group.

Proxalutamide significantly and continuously reduced SARS-CoV-2 viral load

●Proxalutamide significantly and continuously reduced SARS-CoV-2 viral load from Day 3 to Day 28, compared to the control group (p﹤0.01 on Day 3 and Day 28, respectively).

Proxalutamide improved COVID-19 related symptoms

● COVID-19 symptoms such as fever, shortness of breath, and cough were improved through Day 28 compared to patients in the control group. 

Safety:

Proxalutamide continues to demonstrate a positive safety profile

● The study demonstrated that proxalutamide was well tolerated and side effects were manageable in patients with mild to moderate COVID-19. The incidence of treatment-emergent adverse events (TEAEs) was comparable in the control and proxalutamide groups (7.9% and 9.6%, respectively). The majority of TEAEs were mild. The most common adverse event was dizziness (1.1 % in both proxalutamide and control groups). The incidence of any other adverse events was less than 1%. There was no serious adverse event in the study.

Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharma commented, “The top-line data of this pivotal study demonstrates the clinical efficacy of proxalutamide in the mostly US COVID-19 population with a significant reduction of hospitalization and death rate in patients. It is important to note that proxalutamide has showed COVID-19 viral load reduction against both Delta and Omicron variants, which is important as new variants continue to arise. The continued increase in COVID-19 cases serves as a reminder that the world urgently needs effective and safe oral drugs with different mechanisms of action. Kintor plans to actively apply for emergency use authorization (EUA)/emergency approvals from healthcare authorities in China, the United States, and other countries. Separately, I’d like to thank the patients and doctors who participated in the trial and highlight the tireless work of Kintor’s team since the start of the pandemic, their ability to overcome multiple challenges, and to thank them for their continued efforts.”

 

About the Study 

The multi-center randomized, double-blind, placebo-controlled (1:1) registrational trial (NCT04870606), evaluated the efficacy and safety of proxalutamide in outpatients with mild to moderate COVID-19 illness. The study enrolled 733 male and female patients with a positive SARS-CoV-2 diagnostic test and symptoms onset whether vaccinated or not and regardless of risk factors. Ninety-nine percent (99%) of the patients were recruited in the United States. The patients received either proxalutamide 200mg, once daily plus standard of care (SOC)(“proxalutamide arm”) or placebo plus SOC (“placebo arm”) for 14 consecutive days.

The study endpoints included the percentage of patients who did not experience all-cause hospitalization for at least 24 hours, or did not require supplemental oxygen for at least 24 hours in response to SpO2 ≤93% and were alive by Day 28; the proportion of patients with all-cause hospitalization (defined as ≥24 hours), requiring supplemental oxygen orall-cause death by Day 28, and changes of SARS-Cov-2 viral load frombaseline to Day 28 as well as safety assessments.

About Proxalutamide

Proxalutamide is an ACE2 (angiotensin-converting enzyme 2) and TMPRSS2 (transmembrane protease, serine 2) proteins inhibitor that inhibits the entry of the SARS-CoV-2 virus into host cells. For COVID-19 patients with early symptoms, targeting the ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells. For severe patients, proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which inhibits the over-production of IL-6, proinflammatory cytokines, and chemokines, thus minimizing cytokine storms and tissues damage. In this way, proxalutamide might be well-positioned as an effective drug for COVID-19 patients from early symptoms to hospitalized/severe conditions.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancers, alopecia and acne. For more information, visit www.kintor.com.cn.