Kintor Pharmaceutical Limited has announced positive results from its Phase III clinical trial of KX-826, a topical androgen receptor (AR) antagonist, for the treatment of androgenetic alopecia (AGA), commonly known as hair loss. The trial achieved its primary endpoint, demonstrating a statistically significant increase in target area hair count (TAHC) compared to placebo after 24 weeks of treatment.
The multi-center, randomized, double-blind, placebo-controlled trial enrolled male patients with AGA. Participants were administered KX-826 topically twice daily. The primary efficacy endpoint was the change from baseline in TAHC at week 24. Secondary endpoints included patient self-assessment scores and investigator global assessment.
According to the company, KX-826 exhibited a favorable safety profile. Systemic exposure to the drug was minimal, and the incidence of adverse events was low and comparable to the placebo group. Specific details regarding adverse events were not disclosed in the announcement.
"These Phase III results are encouraging and suggest that KX-826 could offer a new therapeutic option for individuals suffering from androgenetic alopecia," said a Kintor spokesperson. "We are committed to further developing KX-826 and bringing it to market to address the unmet needs of patients with hair loss."
Androgenetic alopecia is a common dermatological condition affecting both men and women. It is characterized by a progressive decrease in hair follicle size and hair density, leading to thinning and eventual baldness. Current treatment options include topical minoxidil and oral finasteride, but these therapies have limitations in terms of efficacy and potential side effects. KX-826, with its novel mechanism of action as a topical AR antagonist, may provide an alternative approach to managing AGA.
Further details from the trial, including specific TAHC data and secondary endpoint results, are expected to be presented at upcoming scientific conferences and in peer-reviewed publications.
