Pioneer Pharmaceutical-B (09939): KX-826 Tincture 1.0% key clinical trial for androgenic alopecia treatment in adult Chinese men completed the first patient enrollment

According to the Zhitong Finance App, Kaituo Pharmaceutical-B (09939) announced that on October 15, 2024, its self-developed and potentially first-of-its-kind KX-826 tincture 1.0% to treat androgenic alopecia (“AGA” or “alopecia”) in adult Chinese men (“AGA” or “alopecia”) completed the first case of the subject. This critical clinical trial is a multi-center, randomized, double-blind, excipient-controlled phase II/III adaptive design study to evaluate the efficacy and safety of 1.0% topical treatment of KX-826 tincture in Chinese adult male AGA patients.

This critical clinical trial uses a seamless phase II/III operation design, that is, a 2-in-1 design. Professor Zhang Jianzhong and Professor Zhou Cheng of Peking University People's Hospital are the main researchers. This key clinical trial includes two stages, phase II dose exploration phase (“phase II phase”) and phase III confirmatory phase (“phase III phase”). The phase II trial is planned to be carried out at 10 clinical research centers across the country, and the phase III trial is planned to be carried out at 25 clinical research centers across the country.

This phase II phase included three treatment groups: KX-826 tincture 0.5% BID (twice daily) group (low dose group), KX-826 tincture 1.0% BID group (high dose group), and KX-826 tincture excipient group (control group). The three groups were distributed according to 1:1:1. Each group enrolled 30 patients (that is, 90 patients in total), and treated for 24 weeks according to the prescribed dosage.

This phase III phase included three treatment groups: KX-826 tincture 0.5% BID group (low dose group), KX-826 tincture 1.0% BID group (high dose group), and KX-826 tincture excipient group (control group). The three groups were distributed according to 1:1:1. Each group enrolled 222 patients (i.e. 666 patients in total), and treated for 24 weeks according to the prescribed dosage

The company's pre-clinical research showed that compared to the 0.5% dosage form of KX-826 tincture used in the previous phase III clinical trial, the 1.0% dosage form of this tincture significantly increased the residual concentration on human scalp cells, which is expected to improve clinical efficacy. Clinical trials of KX-826 tincture of 1.0% are expected to maintain excellent safety and show more significant curative effects compared to KX-826 tincture of 0.5%.

In addition, the company announced the latest developments in the Phase III clinical trial on the long-term safety of KX-826 to treat hair loss. This long-term safety clinical trial is a multi-center, open-label study aimed at evaluating the long-term safety of KX-826 topical treatment for hair loss patients in China (treatment time 52 weeks). The long-term safety clinical trial was conducted at 16 clinical research centers across the country, with Professor Zhang Jianzhong of Peking University People's Hospital as the main researcher. The primary end point of this test was the occurrence of adverse events (“TEAE”) that occurred during the study. Secondary endpoints included efficacy indicators such as changes in the number of non-scaly hairs (“TAHC”) in the target area compared to baseline and other safety indicators. In this test, KX-826 tincture 0.5% BID was used as the dosage for the study drug. The results of the analysis of 95 male patients who completed 52 weeks of treatment showed:

In terms of security. KX-826 tincture was generally safe and well tolerated, and no serious adverse effects (“SAE”) associated with the tested drug occurred. A common (incidence rate ≥ 5%) treatment-related adverse event (“TRAE”) is itching at the site of administration, which is mostly mild and does not affect the daily life of the subjects.

Effectiveness aspects. After 12 weeks, 24 weeks, 36 weeks, and 52 weeks of treatment, TAHC and the target region's non-hair diameter (“TAHW”) both increased from baseline. Among them, TAHC increased by 9.5%, 13.0%, 11.4%, and 9.7%, respectively, and TAHW increased by 12.1%, 18.6%, 15.7%, and 10.0%, respectively. The results were all statistically significant. This result was significantly superior to the previous 0.5% increase in TAHC at week 24 from baseline in the phase III clinical trial.

In week 24, the proportion of subjects with a change of at least 10 roots per cm2 compared to the baseline was 60.2%, the proportion of subjects with a change of at least 20 roots per cm2 was 28.9%, and the proportion of subjects with a change of at least 30 roots per cm2 was 18.0%. In week 52, the proportion of subjects with a change of at least 10 roots per cm2 compared to the baseline was 48.4%, the proportion of subjects with a change of at least 20 roots per cm2 was 20.4%, and the proportion of subjects with a change of at least 30 roots per cm2 was 11.8%.

The researchers and subjects' hair growth assessment (“HGA”) indicators improved to varying degrees compared to the baseline, showing trends in efficacy. The results showed that after 12 weeks, 24 weeks, 36 weeks, and 52 weeks of treatment, the hair growth of 60.9%, 69.5%, 64.0% and 54.0% of the subjects improved compared to the baseline (HGA score ≥1), respectively.