Kintor Pharmaceutical has concluded the enrolment of 180 subjects in the Phase II clinical trial of GT20029 to treat male androgenetic alopecia (AGA) patients in China.
The placebo-controlled, double-blind, randomised, multi-centre study will be carried out at 12 clinical research centres in the country.
Fudan University Huashan Hospital’s professor Yang Qinping will act as the leading principal investigator (PI) of the trial.
The trial intends to assess the safety and efficacy of the in-house developed, first-in-class proteolysis targeting chimera (PROTAC) compound GT20029 in male AGA patients.
Change from baseline in non-vellus target area hair counts (TAHC) after treatment for 12 weeks, compared to a placebo, is the primary endpoint of the study.
GT20029 has also demonstrated a good safety profile and tolerability in previous Phase I clinical trials conducted in China and the US in more than 200 subjects.
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Patients in these studies were administered with single and multiple doses of topical applications of GT20029.
Kintor Pharmaceutical founder, chairman and CEO Dr Youzhi Tong said: “We would like to thank all the PIs from the centres and the company’s medical and clinical operation staffs for their joint efforts to finish the patients enrolment in the Phase II clinical trial of GT20029 in about four months.
“We expect to release the top-line data of the Phase II clinical trial in the first quarter of 2024 and look forward to collecting more efficacy and safety data of GT20029 in this trial.”