Kintor Pharma has announced that its GT20029 Phase II trial in China has met the primary endpoint, showing significant results in treating male androgenetic alopecia (AGA).

The trial evaluated the efficacy and safety of Kintor Pharma’s in-house developed first-in-class androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound, GT20029 tincture.

Kintor said the Phase II trial, which is a multi-centre, randomised, double-blind, placebo-controlled study, demonstrated both statistical and clinical significance, as well as good safety and tolerability.

Led by Fudan University Huashan Hospital professor Yang Qinping, the trial involved 180 male AGA patients, divided into once daily (QD) and twice weekly (BIW) dosing cohorts, each with control groups (dosing placebo) and experiment groups (dosing GT20029 tincture) getting either 0.5% or 1% doses.

The patients were enrolled across 12 clinical research centres in China.

The trial’s primary endpoint was the change from baseline in non-vellus target area hair counts (TAHC) after 12 weeks of treatment compared to placebo.

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The results indicated that GT20029 tincture showed statistically significant therapeutic efficacy and clinical significance as against placebo in both the QD and BIW dosing cohorts.

The 0.5% QD group saw an increase of 16.80 hairs/cm², and the 1% BIW group saw an increase of 11.94 hairs/cm², both surpassing placebo results with statistical significance.

In terms of safety, GT20029 showed a comparable incidence of adverse events to placebo, with no adverse sexual events reported.

The Phase II trial recommended 1% BIW dosage for the Phase III trial for male AGA in China.

Kintor Pharma founder, chairman and CEO Dr Youzhi Tong said: “The conclusion of Phase I clinical trials in China and the US has provided crucial safety and pharmacokinetics data at both local and systemic levels. Our phase II clinical trial has further affirmed the safety profile of this innovative PROTAC technology for sustained local applications.

“More importantly, our trial is the first one to demonstrate the initial therapeutic benefits of topical PROTAC compound. A better AGA treatment calls for fast efficacy, superior results, and reduced administration frequency. We are poised to demonstrate these objectives in our upcoming GT20029 clinical trials.”

Developed using Kintor Pharma’s PROTAC platform, GT20029 is claimed to be the world’s first dermatological topical novel AR degrader.

It targets AR proteins for degradation, acting locally on skin tissues to reduce AR sensitivity to androgens in hair follicle sebaceous glands, making it suitable for treating both AGA and acne.