Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the commencement of patient enrollment in a pivotal Phase II/III study for its KX-826 tincture 1.0%. The study aims to evaluate the efficacy and safety of the treatment in adult males with androgenetic alopecia (AGA) in China.
Preclinical data for the KX-826 tincture 1.0% formulation indicates a significant increase in retention concentration on human scalp cells compared to the 0.5% formulation used in previous trials. This advancement is anticipated to enhance clinical efficacy. The new clinical trial is expected to uphold the excellent safety profile of the KX-826 tincture while demonstrating improved efficacy over the 0.5% formulation.
In related news, the long-term safety Phase III study for KX-826 in alopecia, initiated in July 2023, has reported interim results. Among the 95 male patients who completed 52 weeks of treatment, KX-826 tincture exhibited overall good safety and tolerability, with no serious adverse reactions attributed to the investigational drug. Improvements in hair growth were observed in 60.9%, 69.5%, 64.0%, and 54.0% of subjects after 12, 24, 36, and 52 weeks of treatment, respectively, compared to baseline.- Flcube.com
