Successful Phase II Trial for GT20029 in Treating Male AGA in China

3 June 2024
Kintor Pharmaceutical Limited, a company engaged in the development of innovative pharmaceuticals, has announced positive results from a phase II clinical trial of their novel compound GT20029. The trial focused on the treatment of male pattern hair loss, a condition known as androgenetic alopecia (AGA). The study was conducted across multiple centers in China and was led by Professor Yang Qinping from Fudan University Huashan Hospital.

The clinical trial was a randomized, double-blind, and placebo-controlled study, designed to evaluate the effectiveness and safety of GT20029. It aimed to establish the optimal dosage for a phase III trial. The compound was tested on 180 male participants suffering from AGA, who were divided into two dosing groups: once daily and twice weekly, with each group having both control and experimental arms.

The results indicated that GT20029 showed significant therapeutic benefits over the placebo in both dosing groups. Specifically, the once daily application of 0.5% GT20029 led to a statistically significant increase in hair count compared to the placebo. Similarly, the twice weekly application of 1% GT20029 demonstrated a dose-dependent response and also showed a significant increase in hair count from baseline.

In terms of safety, GT20029 was well-tolerated with a safety profile comparable to the placebo. No serious adverse events related to sexual function were reported during the trial. The optimal dosage identified from the study was the 1% twice weekly application, which will be used in the upcoming phase III clinical trial in China.

GT20029 is a groundbreaking topical androgen receptor (AR) degrader, developed using Kintor Pharma's proprietary PROTAC platform. It is the first of its kind to have completed phase I clinical trials in both China and the U.S. The compound works by degrading AR proteins, which helps in reducing the sensitivity of hair follicle sebaceous glands to androgens, thus promoting hair growth.

Dr. Youzhi Tong, the CEO of Kintor Pharma, highlighted the significance of the trial's success, emphasizing the innovative nature of the PROTAC technology and its potential in providing a superior treatment option for AGA. The company is now gearing up for further clinical trials to demonstrate the compound's efficacy, safety, and convenience in treating AGA and other skin conditions such as acne.

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