Kintor Pharmaceutical has dosed the first subject in the Phase II clinical trial of KX-826 (pyrilutamide) to treat male androgenetic alopecia (AGA) in the US.
An androgen receptor (AR) antagonist, KX-826 is a topical drug to treat AGA and acne vulgaris.
The randomised, double-blind, placebo-controlled, parallel-group trial will assess the safety and efficacy of KX-826 to treat AGA in nearly 120 adult males.
The change from baseline in non-vellus target area hair counts (TAHC) at week 24 is the trial’s primary endpoint.
In July last year, the US Food and Drug Administration had granted approval to commence phase II trial of KX-826 for AGA in the country.
The company reported that the Phase II trial of KX-826 in adult male AGA patients met the primary endpoint in September last year.
KX-826 also demonstrated safety profile.
Kintor Pharma founder, chairman and CEO Dr Youzhi Tong said: “As a topical AR antagonist, KX-826’s Phase I and Phase Ib clinical trials in the US have demonstrated a preliminary positive 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.”
In February this year, the company dosed the first subject in a Phase I trial of GT20029 (gel) in the US for AGA and acne.
The double-blind, randomised, parallel-group, placebo-controlled, dose-escalation trial is designed to evaluate the safety, tolerability and pharmacokinetics of GT20029.