Zhitong Finance App News, Kaituo Pharmaceutical-B (09939) issued an announcement. The board of directors of the company is pleased to announce that the Chinese phase II clinical trial for topical treatment of androgenic alopecia in men with a novel proteolytic chimeric compound targeting androgen receptors has reached the main research end. The results are statistically significant and clinically significant, and the safety and tolerability are good. GT20029 Based on the results of this phase II clinical trial, the company will actively deploy subsequent clinical strategies for GT20029, such as carrying out a phase III clinical trial for male hair loss in China and a phase II clinical trial in the US. Additionally, the company is preparing to conduct a phase II clinical trial of GT20029 for acne treatment.
This phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GT20029 tincture in treating male hair loss and to determine the recommended dosage for the phase III clinical trial. The trial was carried out at 12 centers across the country, with Professor Yang Qinping of Huashan Hospital affiliated to Fudan University as the main researcher (leading PI). The main efficacy end point of the trial was the average change in the number of non-moles in the target area compared to the baseline after 12 weeks of treatment compared with placebo. The safety assessment included adverse events, laboratory tests, subjective evaluation of topical medication, and evaluation of skin damage. A total of 180 male alopecia patients were included in the trial, which were divided into a daily medication cohort and a twice-weekly medication cohort. Each cohort included a control group (using a placebo) and a trial group (using GT20029 tincture), and received different doses of 0.5% and 1%. The results showed:
In terms of efficacy, compared with placebo, GT20029 tincture showed statistically significant efficacy advantages and clinical significance, whether in the QD cohort or BIW cohort. After 12 weeks of treatment, TAHC in the 0.5% QD group of GT20029 increased by 16.80 roots/cm2 from baseline and 6.69 roots/cm2 compared to placebo. The results were all statistically significant (P<0.05). GT20029 1.0% of the BIW group had an increase of 11.94 units/cm2 of TAHC from baseline and 7.36 abouts/cm2 compared to placebo. The results were all statistically significant (P<0.05). In the BIW cohort, studies have shown dose-effect relationships between different GT20029 dose groups.
In terms of safety, GT20029 tincture has good safety and tolerability, and the adverse events that occurred during treatment in each group were comparable to placebo. Furthermore, no adverse events related to sexual function were observed in the trial.
GT20029 1% BIW was the optimal dosage for the phase II clinical trial, and this dose was determined as the recommended dosage for the phase III clinical trial of male alopecia in China.
As the world's first novel AR degradant for external use in dermatology, GT20029 was developed based on the company's own PROTAC platform, and is the first topical PROTAC compound to complete phase I clinical trials in both China and the US worldwide. Its role is to recruit AR proteins to E3 ubiquitin ligase for degradation. GT20029 acts on local tissues of peripheral skin, not only avoids systemic exposure to drugs, but also reduces the sensitivity of AR itself to androgens in the sebaceous glands of local hair follicles, so the Group developed it to treat hair loss and acne.