GT20029 China Phase II Trial For AGA Reached Primary Endpoint

SUZHOU, China, April 22, 2024 /PRNewswire/ — Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the China phase II clinical trial (the "Phase II Clinical Trial") of its in-house developed first-in-class androgen receptor ("AR") proteolysis targeting chimera ("PROTAC") compound GT20029 tincture for the treatment of male androgenetic alopecia ("AGA") has reached the primary endpoint, with statistically significant and clinically meaningful results, as well as good safety and tolerability. Based on the results of the Phase II Clinical Trial, the company will actively deploy subsequent clinical strategies for GT20029, such as initiating a phase III clinical trial in China and a phase II clinical trial in the U.S. for male AGA. In addition, the company is also preparing to conduct a phase II clinical trial of GT20029 for the treatment of acne.

The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 for treating male AGA, and to determine the recommended dosage for phase III clinical trial. This trial involves a total of 12 clinical research centers in China, and Professor Yang Qinping from Fudan University Huashan Hospital is the leading principal investigator (leading PI). The primary endpoint of this trial is the average change from baseline in non-vellus target area hair counts ("TAHC") after 12 weeks of treatment in comparison to placebo. Safety assessments included adverse events, laboratory tests, subjective evaluations of the topical medication and dermatological assessments. The trial enrolled 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), receiving either 0.5% or 1% doses. The results showed:

In terms of efficacy, GT20029 tincture demonstrated statistically significant therapeutic efficacy and clinical significance compared to placebo in both the QD and BIW dosing cohorts. After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs/cm² from baseline, which was 6.69 hairs/cm² more than the placebo group, with statistically significant results (P<0.05). The TAHC of GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² from baseline, which was 7.36 hairs/cm² more than the placebo, also yielding statistically significant results (P<0.05). For the BIW cohort, the study indicated a dose-response relationship among different doses of GT20029. Regarding safety, GT20029 tincture demonstrated good safety and tolerability, with the incidence of adverse events during treatment comparable to that of placebo. In addition, no adverse sexual events were observed during the trial. The 1% BIW dosage of GT20029 was identified as the optimal dosing level in the Phase II Clinical Trial and has been recommended for the phase III clinical trial for male AGA in China.

As the world’s first dermatological topical novel AR degrader developed using the company’s in-house developed PROTAC platform, GT20029 is the first topical PROTAC compound that has completed phase I clinical trials both in China and the U.S.. It works by targeting AR proteins for degradation via recruitment to E3 ubiquitin ligase. GT20029 acts locally on peripheral skin tissues, avoiding systemic exposure and reducing the sensitivity of AR to androgens in local hair follicle sebaceous gland. Hence, it is developed by the Group for treating both AGA and acne.

Dr. Youzhi Tong, the founder, chairman and CEO of Kintor Pharma, said, "As the pioneering topical PROTAC drug, GT20029’s phase II clinical trial has attracted significant attention. The conclusion of phase I clinical trials in China and the U.S. 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 for calls for fast efficacy, superior results, and reduced administration frequency. We are poised to demonstrate these objectives in our upcoming GT20029 clinical trials."

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