Kintor Announces US Phase 2 Trial Results In Male AGA
On May 11, 2023, Kintor Pharmaceutical of China announced results from their US phase 2 trial testing KX-826 aka pyrilutamide in males with androgenetic alopecia.
Successful Phase 2 Trial For US KX-826 Trial
As is the trend for Kintor Pharmaceutical’s AGA programs, today’s announcement included positive results in a human trial. This milestone will help Kintor Pharmaceutical progress to a pivotal phase 3 clinical trial in the US, and it was mentioned in today’s release stated that the company is preparing for meetings with US FDA to discuss the phase 2 results and the potential initiation of a phase 3 trial. Details and results from the completed US phase 2 trial are as follows:
- The US phase 2 AGA trial included 93 male subjects who were randomly assigned to KX-826 dosage or placebo groups.
- Male subjects met the criteria of having hair loss between grades 3-5 on the Norwood scale.
- The TAHC of the 0.5% BID (twice daily) KX-826 group increased by about 10 hair counts per cm2 compared with baseline after the treatment of 24 weeks, which was statistically significant.
- KX-826/pyrilutamide 0.5% BID (twice daily) was determined to be the optimal dose and recommended dose for the upcoming phase 3 trial (this was the same dose selected for the China phase 3 trial)
- KX-826 demonstrated a favorable safety profile in male AGA treatment. Most of the treatment emerged adverse events were mild and classified as local scalp sensitivity similar to those of placebo in terms of occurrences.
Comparison To China Phase 2 Results
Last August, Follicle Thought broke the news of KX-826’s phase 2 results in male AGA in China. In that Chinese study, a 22 hairs per cm² increase was found in TAHC compared to baseline. So, there is a noticeable contrast in the increased hair count of 10 in the target area found in the US study. It has been mentioned and discussed that people of Asian descent respond better to hair growth treatments due to genetic variances. These phase 2 studies appears to add more evidence of that phenomenon.