Kintor Pharmaceuticals has completed a Phase II clinical trial investigating KX-826 in males with androgenetic alopecia (AGA). Alongside the announcement, the China-based biotech reported statistically and clinically meaningful results from the trial, which was conducted in the US.

KX-826 acts as an androgen receptor antagonist. Androgen metabolism plays an important role in the control of both sebum excretion rate and keratinisation patterns in the pilosebaceous unit.

The data analysis showed that KX-826 promoted hair growth compared to baseline and demonstrated statistical and clinically meaningful as measured by target area non-vellus hair count (TAHC). The TACH of the 0.5% twice daily (BID) cohort increased by about 10 hair counts per cm2 compared with baseline after the treatment of 24 weeks.

Additionally, KX-826 indicated an improvement in TAHC compared to the placebo and a dose-response relationship was observed from different dosage groups.

The 0.5% BID dose of KX-826 was determined to be the optimal dose for the Phase II clinical trial, which was also concluded in a Phase II trial in China. This will be the recommended dose for the US-based or international Phase III trial.

KX-826 also demonstrated a favourable safety profile. Most of the treatment-emerged adverse events (TEAE) were mild and the occurrence of local scalp sensitivity was similar to those in the placebo cohort. There were no reported TEAEs that resulted in death or patient withdrawal from the trial.

The Phase II trial design

The Phase II trial (NCT05218642) enrolled 123 male patients with AGA who were classified into stage III vertex, IV or V using the Hamilton-Norwood scale. Amongst them, 93 patients were randomly assigned to 0.25% once daily (QD), 0.5% QD and 0.5% BID cohorts, while 30 patients were enrolled into the placebo group.

The primary endpoint of the trial measured change in TAHC after 24 weeks of treatment compared to placebo. The secondary endpoint investigated Hair Growth Assessment score at weeks six, eight, 18 and 24.

Further KX-826 development

Kintor is now preparing for upcoming discussions with the FDA to discuss Phase II results and plans to initiate a US-based or international Phase III trial.

The company is conducting multiple clinical trials evaluating KX-826 in males and females with AGA in the US and China. In December 2022, the biotech announced that a Phase II trial investigating the drug in females met its primary endpoint.

In March 2023, Kintor completed the enrolment of male patients in a Phase III trial in China, with topline results expected in Q4 2023. The trial started dosing patients in January 2022.

AGA is a genetically predetermined disorder and a common form of hair loss in both sexes. Last year, alopecia, specifically alopecia areata, hit the headlines after comedian Chris Rock was slapped in response to a joke about the disorder at the 94th Academy Awards ceremony. Clinical Trials Arena explored if the spotlight on the disorder will improve research and treatment options.