The success rate of the treatment in each arm as per the five-point IGA scale by week 12 is the trial’s primary endpoint.
Kintor Pharmaceutical has concluded subject enrolment in its Phase II clinical trial in China analysing KX-826 (pyrilutamide) to treat acne vulgaris.
The double-blind, randomised, multi-regional, placebo-controlled trial enrolled a total of 160 subjects.
It will assess the efficacy and safety of KX-826 (gel) in mild to moderate acne vulgaris patients.
The success rate of the treatment in each arm by week 12 as per the five-point Investigator Global Assessment (IGA) scale is the primary endpoint of the trial.
An AR antagonist, KX-826 is a potential topical drug to treat acne vulgaris and androgenetic alopecia (Aga).
The therapy could hinder the androgen receptor and androgen combination in hair follicle sebaceous glands that reduce the production of sebum, eventually treating acne vulgaris.
Kintor Pharma founder, chairman and CEO Dr Youzhi Tong said: “KX-826’s clinical trial in China for treating acne vulgaris was the combined design of Phase I and Phase II clinical trials.
“KX-826’s Phase I clinical trial has demonstrated a preliminary positive safety and tolerability profile in terms of dose-escalation and multiple topical doses applications per day for local use.
“We expect that KX-826 continues to demonstrate good efficacy and safety in Phase II clinical trial to benefit more people suffering from acne vulgaris.”
The company is currently carrying out a Phase III trial of KX-826 for AGA in China, as well as a Phase II trial of KX-826 in the US for men with AGA.
Subsequently, a Phase II trial of KX-826 in female patients with AGA is underway in China.
In August, the company completed patient enrolment in the Phase II trial of KX-826 in male AGA patients in the US.
