Kintor Pharma Announces Successful Completion of Phase II Clinical Trial of KX-826 for Treatment of Androgenetic Alopecia in the US
SUZHOU, China, May 11, 2023. Kintor Pharmaceutical Limited ("Kintor Pharma"), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the Phase II clinical trial of in-house developed KX-826 for the treatment of male androgenetic alopecia ("AGA") in the US has been completed successfully. The results are statistically and clinically meaningful, and demonstrated a favorable safety profile. The company is preparing for subsequent FDA meetings on the results of the Phase II clinical trial, and intends to commence Phase III clinical trial in the US/globally.
Results of the Phase II clinical trial showed that KX-826 promotes hair growth compared to baseline and demonstrated statistical and clinically meaningful as measured by target area non-vellus hair count ("TAHC"). KX-826 has indicated an improvement in TAHC versus placebo, and a dose-response relationship was observed from different KX-826 dosage groups.
The Phase II clinical trial is a randomized, double-blind, placebo-controlled and parallel group study designed to evaluate the efficacy and safety of KX-826 for the treatment of male AGA. A total of 123 male AGA patients, who were classified into stage III vertex, IV or V using the Hamilton-Norwood scale, were enrolled in the Phase II clinical trial. Among them, 93 patients were randomly assigned to different dosage groups, including 0.25% once daily ("QD"), 0.5% QD and 0.5% twice daily ("BID"); and 30 patients were randomly assigned to placebo groups receiving different dosages. The results showed that:
- The TAHC of the 0.5% BID KX-826 group has increased by about 10 hair counts per cm2 compared with baseline after the treatment of 24 weeks, which was statistically significant (P=0.0088).
- KX-826 has indicated an improvement in TAHC versus placebo, and a dose-response relationship was observed from different KX-826 dosage groups. Other relevant results indicated that KX-826 promotes hair growth clinically in male AGA patients.
- Same with the Phase II clinical trial in China, 0.5% BID KX-826 was determined to be the optimal dose in the Phase II clinical trial. 0.5% BID KX-826 was also determined to be the recommended dose for Phase III clinical trial for male AGA in the US/globally.
- KX-826 demonstrated a favorable safety profile in male AGA treatment. In our study, most of the treatment emerged adverse events ("TEAE") were mild and local scalp sensitivity similar to those of placebo in terms of occurrences. No TEAE resulting in patient withdrawal from the trial, nor death was reported.
Multiple clinical trials on KX-826 in China and the US for male and female AGA treatments are currently ongoing. On 1 December 2022, the company announced that the primary endpoint of Phase II clinical trial of KX-826 in China for the treatment of female AGA patients was met. On 28 March 2023, the company announced that the enrollment of patients for the Phase III clinical trial KX-826 in China for the treatment of male AGA was completed, and the top-line data of which was expected to be released in the fourth quarter of 2023.
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for oncology and androgen-receptor-related disease areas with unmet medical needs, including alopecia, acne, COVID-19, prostate cancer, liver and breast cancers. For more information, visit www.kintor.com.cn.
SOURCE Kintor Pharma
Posted: May 2023
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