Kintor Pharma’s Latest KX-826 Trial Reaches Its Primary Endpoint

Earlier this month, Kintor announced that its long-term Phase 3 safety trial of 0.5% KX-826  had reached its primary endpoint with statistically significant and clinically meaningful outcomes. This comes after a history of multiple trials, some with mixed results.

The Trial

This trial was a multi-center (16 centers), open-label study taking place over 52 weeks. 

• The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs).
• Secondary endpoints included change in target non-vellus hair counts (TAHC), target area non-vellus hair width (TAHW), and hair growth assessments (HGA).
• Participants applied 0.5% KX-826 twice daily. 

Results

• KX-826 showed satisfactory safety and tolerability over the trial with a low incidence of adverse events. 
• At 52 weeks, 46% of patients showed a ≥10 hairs/cm2 change in TAHC from the baseline.
  • 20% of patients showed a ≥20 hairs/cm2 change.
• TAHW showed an increase from the baseline.
• Hair growth assessment indicators showed varying degrees of improvement from the baseline.
  • 53% of male participants showed a HGA score ≥1 by 52 weeks.
  • 48.4% of female participants showed a HGA score ≥1 by 52 weeks.

Reflections

Overall, these results appear to be positive. However, previous studies using this concentration have shown mixed results. We would like to see the data published in peer-reviewed journals, rather than press releases. While press releases serve to get key information out quicker, we never get the whole story.

What do you think about these results and about KX-826 as a whole? Let us know in the comments