SUZHOU, China, April 21, 2024 /PRNewswire/ — Kintor Pharmaceuticals Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biologic therapies, announced that THE China phase II clinical trial (the “Phase II Clinical Trial”) of first-in-class androgen receptor (“AR”) in-house developed dye-targeted chimera compound GT20029 (“PROTAC”) for the treatment of alopecia androgenetic male (“AGA”) met the primary endpoint, with statistically and clinically significant results, as well as good safety and tolerability. Based on the results of the Phase II clinical trial, the company will actively implement subsequent clinical strategies for GT20029, such as initiating a Phase III clinical trial in China and a phase II clinical trial in WE for male AGA. Additionally, the company is preparing to conduct a Phase II clinical trial of GT20029 for the treatment of acne.
The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 in the treatment of male AGA and to determine the recommended dosage for the phase clinical trial III. This study involves a total of 12 clinical research centers in Chinaand the professor Yang Qinping from Fudan University Huashan Hospital is the principal principal investigator (principal PI). The primary endpoint of this study is the mean change from baseline in target non-vellus area hair count (“TAHC”) after 12 weeks of treatment compared to placebo. Safety assessments included adverse events, laboratory tests, subjective assessments of topical medication, and dermatological assessments. The study enrolled 180 male AGA patients, divided into once-daily (“QD”) and twice-weekly (“BIW”) dosing cohorts, each with control (placebo dosing) and experimental (placebo dosing) groups. tincture GT20029), who received 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 QD GT20029 0.5% group showed an increase of 16.80 hairs/cm² compared to baseline, i.e. 6.69 hairs/cm² more than the placebo group, with statistically significant results (P). The TAHC of the GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² compared to baseline, i.e. 7.36 hairs/cm² more than the placebo, also obtaining statistically significant results (P). For the BIW cohort, the study indicated a dose-response relationship between different doses of GT20029.
- Regarding safety, GT20029 dye demonstrated good safety and tolerability, with an incidence of adverse events during treatment comparable to that of placebo. Furthermore, no adverse sexual events were observed during the study.
- The 1% BIW dosage of GT20029 was identified as the optimal dosage level in the Phase II clinical trial and was recommended for the Phase III clinical trial for male AGA in China.
As the world’s first dermatological topical AR degrader developed using the company’s in-house developed PROTAC platform, GT20029 is the first topical PROTAC compound to have completed Phase I clinical trials in both China and the WE. It works by targeting AR proteins for degradation via recruitment to the E3 ubiquitin ligase. GT20029 acts locally on peripheral skin tissues, avoiding systemic exposure and reducing the sensitivity of RA to androgens in the local sebaceous gland of the hair follicle. Therefore, it is developed by the Group for the treatment of both AGA and acne.
Dr. Youzhi Tongfounder, president and CEO of Kintor Pharmasaid, “As a pioneering PROTAC topical drug, the Phase II clinical trial of GT20029 has attracted significant attention. The conclusion of the Phase I clinical trials in China and the WE provided crucial safety and pharmacokinetic data at both local and systemic levels. Our Phase II clinical study further affirmed the safety profile of this innovative PROTAC technology for prolonged local applications. More importantly, our study is the first to demonstrate initial therapeutic benefits of the topical PROTAC compound. Better AGA treatment requires rapid efficacy, superior results and reduced frequency of administration. We are ready to demonstrate these objectives in our upcoming GT20029 clinical trials.”
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