お知らせ • Oct 16
Kintor Pharmaceutical Limited Announces Completion of First Subject Enrollment in Pivotal Clinical Trial of Kx-826 Tincture 1.0% for the Treatment of Men Adult Androgenetic Alopecia in China
The board of directors of Kintor Pharmaceutical Limited announced that on 15 October 2024, the Company has completed the first subject enrollment in the pivotal clinical trial (the "Pivotal Clinical Trial") of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of male adult androgenetic alopecia ("AGA") in China. The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-8 26 tincture 1.0%. The Pivotal Clinical Trial adopts a phase II/III operational seamless design, namely 2-in-1 design, with Professor Jianzhong Zhang (Zhang Jian Zhong) and Professor Cheng Zhou (Zhou Cheng) from Peking University People's Hospital as the lead principal investigator. The Pivotal Clinical trial includes two phases, phase II dose exploration stage (the "Phase II Stage") and phase III confirmatory stage (the "Phase III Stage"). The Phase II Trial is expected to involve 10 clinical research centers in China, whereas the Phase III Trial is expected to involve 25 clinical research centers in China. The Phase II Stage involves three treatment groups, namely, KX-826 tincture 0.5% BID (twice-a-day) group (low-dose group), KX-826 tincture 1.0% BID group (high-dose group), and KX-826 tincture vehicle group (control group) in a 1:1:1 allocation ratio. 30 patients will be enrolled in each group (i.e.
90 patients will be enrolled in total), who will receive treatment with the stipulated dosages over a period of 24 weeks. The Phase III Stage involves three treatment groups, namely, KX-826 tincture 0.5% BID group (low- dose group), KX-826 tincture 1.0% BID group (high-dose group), and KX-826 tincture vehicle group (control group) in a 1:1:1 allocation ratio. 222 patients will be enrolled in each group (i.e. 666 patients will be enrolled in total), who will receive treatment with the stipulated dosages over a period of 24 weeks. The Company's preclinical studies have shown that the KX-826 tincture 1.0% has significantly increased the retention concentration of the tincture on human scalp cells compared to the KX-826 tincture 0.5% used in the previous phase III clinical trial, and is expected to enhance the clinical efficacy. The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety profile and present superior efficacy compared to the KX-826 tincture 0.5%. The Long-term Safety Clinical Trial is a multi-center, open-label study designed to evaluate the long-term safety of the topical use of KX-826 for the treatment of AGA patients in China (treatment period of 52 weeks). The Long-term Safety Clinical Trial involves a total of 16 clinical research centers in China, with Professor Jianzhong Zhang () from Peking University People's Hospital as the lead principal investigator. The primary endpoint of the trial is the incidence of treatment-emergent adverse events ("TEAE") occurred during the study. Secondary endpoints include efficacy as measured by the change in the target area non-vellus hair counts ("TAHC") from baseline and other safety indicators. This trial adopted KX-826 tincture 0.5% BID as the drug-related dosage. The analysis results of 95
male patients who completed 52 weeks' treatments showed: Regarding safety, KX-826 tincture demonstrated great safety and tolerability as a whole, without any serious adverse events ("SAE") related to the drug reported. The common (incidence5%) treatment related adverse events ("TRAE") were itching at application sites, and most of them were mild, not affecting the daily life of patients. In terms of efficacy, after 12, 24, 36 and 52 weeks' treatment, both TAHC and target area non-vellus hair width ("TAHW") showed an increase from baseline, among which, the TAHC increased by 9.5%, 13.0%, 11.4% and 9.7% respectively, TAHW increased by 12.1%, 18.6%, 15.7% and 10.0% respectively, with statistically significant results. Such results were significantly better than the results from the previous 0.5% phase III clinical trial at 24 weeks. At 24 weeks, the patients with 10 hairs/cm2 change in TAHC from baseline accounted for 60.2%, the patients with 20 hairs/cm2 change accounted for 28.9%, the patients with 30 hairs/cm2 change accounted for 18.0%. At 52 weeks, the patients with 10 hairs/cm2 change in TAHC from baseline accounted for 48.4%, the patients with 20 hairs/cm2 change accounted for 20.4%, the patients with 30 hairs/cm2 change accounted for 11.8%. The hair growth assessment ("HGA") indicators from investigators and patients both experienced various degrees of improvement from baseline, demonstrating a trend in efficacy. The results showed that as assessed by investigators, 60.9%, 69.5%, 64.0% and 54.0% of patients saw mprovements in their hair growth from baseline after the treatment of 12, 24, 36 and 52 weeks respectively (HGA score 1).