Kintor Reports Results for KX-826 + Minoxidil Combo for Androgenic Alopecia

More news is coming out of Kintor Pharma this month.

Kintor Pharma (HKEX: 9939) has announced that its observational study evaluating the combination of KX-826 and minoxidil for the treatment of androgenetic alopecia (AGA) in adult males in China has successfully reached its primary endpoint. This marks another milestone in the development of KX-826, following several prior studies, some of which produced mixed outcomes.

The Study

Initiated in March 2024, this was a small-scale, open-label, randomized controlled trial conducted at two research centers in China. The goal was to gather data on efficacy, dosing, and patient selection to help design a larger, formal Phase 3 trial.

A total of 75 male patients were enrolled and split between two arms: 40 received a combination of KX-826 tincture (0.5%, twice daily) and minoxidil (5%, twice daily), while 35 received minoxidil monotherapy. The primary endpoint was the change in target area non-vellus hair counts (TAHC) from baseline after 24 weeks. Secondary endpoints included hair growth assessments (HGA) from both investigators and patients. Safety, local tolerance, and adverse events were also monitored.

Results

The combination group showed a statistically significant improvement in TAHC, with an average increase of 30.54 hairs/cm², 10.29 more than the monotherapy group (P=0.0075).

• 30 patients in the combination group saw ≥20 hairs/cm² growth, compared to 19 in the monotherapy group.
• 10 patients in the combination group achieved ≥40 hairs/cm², while only one in the minoxidil group did.
• All patients with no hair count improvement were in the monotherapy group.

The HGA assessments (subjective evaluations made separately by the investigators and patients) showed that both groups improved, but the group receiving the combination treatment performed slightly better. 

Investigator HGA Scores 

• At Week 24, a total of 24 patients received a score of 3 from investigators (on a standardized scale, with higher scores indicating better improvement). Of those:
  • 14 patients were from the Combination Drugs Group
  • 10 patients were from the Minoxidil Group

Patient HGA Scores

• Looking at patient-reported outcomes, 15 patients rated their own hair growth at score 3. Of those:
  • 8 patients were in the Combination Drugs Group
  • 7 patients in the Minoxidil Group

In short, both doctors and patients saw better results in the combination therapy group, though the difference in HGA scores between the two groups was modest, especially in the patient assessments. 

Both treatment arms demonstrated good safety profiles, with no unexpected adverse events and comparable tolerability.

Reflections

These findings suggest that combining KX-826 with minoxidil could improve treatment outcomes for AGA patients. However, as with all of Kintor’s press releases we can’t actually see the difference between the two treatments, which may not be that obvious. 

What do you think about these results? Let us know in the comments.