The trial will assess the efficacy and safety of KX-826 (gel) in mild to moderate acne vulgaris patients. Credit: AdoreBeautyNZ from Pixabay.

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.

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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). 

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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. 

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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.