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EQS-News News vom 11.01.2021

Kintor's Proxalutamide (GT0918) COVID-19 Clinical Trial Shows Positive Re-sults in Treatment of Male and Female Patients

EQS-News / 11/01/2021 / 09:55 UTC+8

Kintor's Proxalutamide (GT0918) COVID-19 Clinical Trial Shows Positive Results in Treatment of Male and Female Patients

Suzhou, Jan 10, 2021--Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to update the preliminary analysis of the clinical trial of Proxalutamide for the treatment of COVID-19 patients. The investigator initiated trial conducted by Dr. Andy Goren and Dr. Flávio Adsuara Cadegiani, shows promising results in the treatment of COVID-19 for both male and female patients.

Proxalutamide is a new androgen receptor (AR) antagonist developed in by Kintor Pharmaceutical. The Clinical Trial (ClinicalTrials.gov identifier: NCT04446429) is a randomised, double-blind and placebo-controlled clinical trial, designed to explore the efficacy of Proxalutamide in the treatment of COVID-19, and aims to prevent the transition of the patients' condition from mild to severe by inhibiting the replication and reproduction of the SARS-CoV-2 coronavirus. The co-primary endpoints of the clinical trial are the percentage of subjects hospitalized with COVID-19 and the COVID-19 Ordinal Outcome Scale (a 8-point ordinal scale used by the US National Institute of Allergy and Infection Diseases, such as mechanical ventilation usage and death) in 30 days.

Final Results for Male Patients

On Jan 7, 2021, Kintor Pharmaceutical released the final results for male patients from the Clinical Trial of Proxalutamide for the treatment of COVID-19. The Final Results showed that Proxalutamide could significantly inhibit the transition of condition of male patients infected with COVID-19 from mild to severe and had good safety for short-term administration (15 days).

The final results included data of 134 male patients in the Proxalutamide arm and 128 male patients in the Control arm, which showed that no patients were hospitalised in the Proxalutamide arm (0%), as compared to 35 patients were hospitalised in the Control arm (27.3%) due to the worsening of the patients' condition. The final results showed that Proxalutamide could significantly reduce the hospitalisation rate of patients infected with COVID-19 and no adverse events related to Proxalutamide were observed during the Clinical Trial. The hospitalisation rate, percentage of ICU usage, mechanical ventilation usage and death within 30 days in the Proxalutamide Arm was 0%, 0%, 0% and 0%, respectively, compared to 27.3%,14.1%, 10.2% and 1.6% in the Controlled Arm. The table below sets forth the Interim Results in terms of hospitalisation, ICU usage, mechanical ventilation usage and death:

	Proxalutamide Arm （n=134）		Controlled Arm （n=128）
	Cases	Percentage	Cases	Percentage
Hospitalisation	0	0%	35	27.3%
ICU usage	0	0%	18	14.1%
Mechanical ventilation usage	0	0%	13	10.2%
Death	0	0%	2	1.6%

This trial commenced the enrolment of 168 post-menopause female patients on Nov, 2020 after receiving the encouraging results from male patients. Eligible female patients were randomized in a 2:1 ratio to receive either Proxalutamide + standard care (Proxalutamide arm) or Placebo + standard care (Control arm). The treatment cycle lasts 15 days.

Interim Results for Female Patients

The interim analysis conducted on Jan 7, 2021 was based on 60 patients in Proxalutamide arm and 35 patients in the Control arm. The percentage of hospitalization, admission to ICU, mechanical ventilation requirement and death was 1.7% vs. 17.1%, 0% vs. 8.6%, 0% vs. 5.7% and 0%, vs. 2.9% in Proxalutamide and Control arms respectively. The table below sets forth the Interim Results in terms of hospitalisation, ICU usage, mechanical ventilation usage and death:

	Proxalutamide Arm （n=60）		Controlled Arm （n=35）
	Cases	Percentage	Cases	Percentage
Hospitalisation	1	1.7%	6	17.1%
ICU usage	0	0%	3	8.6%
Mechanical ventilation usage	0	0%	2	5.7%
Death	0	0%	1	2.9%

Kintor Pharmaceutical expects to conclude the enrolment of the clinical trial for female patients in February 2021 and finalised the data collection by Q1 2021.

Dr. Tong Youzhi, the founder, Chairman and CEO of Kintor Pharmaceutical, said, "first of all, we would like to give special thanks to all the healthcare workers fighting the worldwide COVID-19 pandemic. Special thanks to the AndroCoV[1][2] 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 male group, the data showed that Proxalutamide could significantly ameliorate symptoms and prevent hospitalization for COVID-19 female patients， which paves the way for our phase III MRCT registrational trial in the near future."