Suzhou, March 1, 2022 - Kintor Pharmaceutical Limited (“Kintor Pharma,” HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced the first patient dosing in its phase II clinical trial of KX-826 ("pyrilutamide") in the US for the treatment of male androgenetic alopecia (AGA) patients on February 28, 2022.

AGA is the most common type of hair loss affecting 50-60 million men and 30-35 million women in the US, but there are few therapeutic options. So, a safer and more effective drug is in urgent need to address the concerns for the people suffering from hair loss.

Dr. Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, " As a topical AR antagonist, KX-826’s phase I and phase Ib clinical trials in the US have demonstrated a preliminary postive safety, pharmacokinetics and tolerability profile in dosing frequency. KX-826 has showed good efficacy and safety profile in the phase II clinical trial in China for the treatment of AGA male patients. We look forward to accelerating the clinical process of KX-826 and benefiting more people suffering from hair loss in China and globally.”

About the trial

The phase II trial (NCT05218642) in the US is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KX-826 for the treatment of AGA in adult males (N=120). The primary endpoint for the trial is the change from baseline in non-vellus target area hair counts (TAHC) at week 24.

About KX-826

KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on 8 September 2021, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on adult male patients was met, as results showed good efficacy and safety profile. On 11 July 2021, Kintor Pharma announced that the Food and Drug Administration of the United States greenlighted KX-826’s phase II clinical trial for AGA to be conducted in the United States. On 31 December 2021, Kintor Pharma announced the first patient dosing in its phase III clinical trial of KX-826 in China for the treatment of male AGA patients, with 26 sites participating in this trial. On 12 November 2021, Kintor Pharma announced the first patient dosing in its phase II clinical trial of KX-826 in China for the treatment of female AGA patients. For the acne vulgaris indication, on 24 January 2022, Kintor Pharma announced the first patient dosing in its phase II clinical trial of KX-826 in China for the treatment of acne vulgaris.