Kintor Pharmaceutical Limited (stock code: 9939.HK, hereinafter referred to as "Kintor" or the "Company") announced that the phase Ib clinical trials of Pyrilutamide (KX-826) against androgenetic alopecia were completed in the United States. All subjects exited the trials. Data analysis, cleaning and summarisation are underway.

Pyrilutamide is the world's first topical AR antagonist the Company is developing for the treatment of androgenetic alopecia, with simultaneous phase I and phase II clinical trials in both China and the United States. The phase Ib clinical trials of Pyrilutamide in the United States— that was completed recently— is a randomised, double-blind, placebo-controlled, parallel-group, and dose-escalation study in healthy male subjects with androgenetic alopecia to evaluate the safety, tolerability and pharmacokinetics of Pyrilutamide following topical multiple ascending dose administration. These trials were primarily designated to determine the dosage (range) and frequency of dosing by observing the safety of multiple administration of Pyrilutamide on the scalp and patient tolerance. The phase Ib trials were originally scheduled to be concluded in May but interrupted by the COVID-19 pandemic in the United States. Despite difficulties, American clinical investigators in charge of the trials and Kintor's operation team in the U.S. managed to re-start enrolment and effectively completed the drug trials on all subjects during a brief slowdown of the outbreak.

Alopecia has become a global issue concerning lots of people. The huge patient population is increasing year by year. However, drugs against alopecia are scarce. It is urgent to develop safer and more effective drugs to address the issue. Kintor's Pyrilutamide is a potential first-in-class topical application for the treatment of alopecia with better safety and efficacy.
"Pyrilutamide is a potential first-in-class innovative drug independently developed by us," Dr Youzhi Tong, founder, Chairman and CEO of Kintor, said. "The phase I and Ib clinical trials of Pyrilutamide in the United States have preliminarily proved good safety and tolerability of multiple topical administration. We are closely communicating with the U.S. Food and Drug Administration (FDA) and earnestly prepare for the subsequent trials. We intend to accelerate the clinical research and launch the drug as soon as possible to address the deficiency in the existing therapies and bring good news to patients with alopecia."