The Phase II clinical trial of Pioneer Pharmaceutical Freitane for the treatment of acne in China completed patient enrollment

Pioneer Pharmaceutical (stock code: 9939.
HK), a biopharmaceutical company focused on the R&D and industrialization of potential first-in-class and best-in-class innovative drugs, announced that its self-developed and potentially best-in-class Phase II clinical trial of Fretan (KX-826) for acne in China has completed the enrollment of all 160 patients on October 14
, 2022.

The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy
of Frithane (gel) after topical administration in patients with mild to moderate acne.
The primary endpoint of the trial was treatment success rates for each group of patients at 12 weeks of treatment (those who reduced their IGA scores to 0-1 and decreased ≥ grade 2 were counted as 'successful' according to the Investigator Overall Assessment (IGA) 5-point scale).

Dr.
Youzhi Tong, Founder, Chairman and CEO of Pioneer Pharmaceutical, said, "We are delighted to see that the Phase II clinical trial in China of Freitane for acne has completed the enrollment of all patients
.
Thanks to all the investigators and the company team who participated in this clinical trial, especially the
principal investigator (Leading PI) Professor Xiang Leihong of Huashan Hospital affiliated to Fudan University.
The clinical trial of Freitane for the treatment of acne is a phase I and phase II clinical trial fusion design, phase I stage preliminarily verified that the drug has good safety and tolerability in the dose ramp and multiple times a day topical administration in acne patients, we expect Freitane to continue to show good efficacy and safety in the phase II stage, and benefit
the acne community as soon as possible.
"

About acne

Acne is the eighth most prevalent disease in the world, occurring during adolescence and mainly affecting the face
.
The number of acne patients worldwide has exceeded 740 million
.
The pathogenesis of acne is complex, and the effect of androgens and their receptor signaling pathways on sebaceous glands and sebum secretion is one of
the important factors causing acne.
In August 2020, the US FDA approved the first androgen receptor (AR) antagonist for the treatment of acne, which is the first acne drug approved by the FDA in the past 40 years, and also proves that the mechanism of action of AR in the treatment of acne is recognized by regulatory approval
.
At present, no androgen receptor inhibitors have been approved for the treatment of acne in China, and there is an urgent need for safe and effective drugs to meet the huge clinical demand
.

About Freithan

Freitane is an AR antagonist that is a potential first-of-its-kind topical drug
for the treatment of androgenetic alopecia and acne.
For acne indications, as a topical AR antagonist with a clear target, Fritanne can inhibit the binding of androgen receptors in the sebaceous glands of hair follicles to androgens by applying and administering the mode of action, thereby reducing sebum production and realizing acne treatment
.
For the indications of androgenetic alopecia, Pioneer Pharmaceutical is conducting phase III clinical trials for the treatment of male androgenetic alopecia in China and phase II clinical trials in the United States, and phase II clinical trials
for female androgenetic alopecia in China.