Kintor Begins KX-826 Phase 3 Trial For Androgenic Alopecia
Kintor Begins Additional Long-Term Safety Study For Men And Women: Update (7/19/23)
Today’s update would have to deemed as unexpected to the majority of us following Kintor’s AGA drug development over the past 3 years. The company has announced an additional long term safety and efficacyphase 3 trialwhich will take place over the course of 52 weeks. This will likely affect the timeline for KX-826/pyrilutamide approval in China by over 1.5 years at minimum.
- Kintor’s additional phase 3 trial will enroll 270 male and female subjects, the first subject has been enrolled as of this week.
- The primary endpoint is the occurrence of treatment emergent adverse events. Secondary endpoint will be change in target area hair count compared to baseline.
The additional data from this trial may help KX-826 gain approval in other territories over the long term. However, for now, it appears that the imminent approval of pyrilutamide in China has been extended to a longer forecast.
Enrollment For Phase 3 Trial Has Completed in China: Update (3/28/23)
Just over a year since the initiation of the phase 3 clinical trial for KX-826 in China, Kintor Pharmaceutical announced the completion of enrollment of 740 male subjects in the phase 3 trial. This means that the necessary number of trial subjects have been entered into the trial, though some are still not done completing their dosing in the trial. Intoday’s releaseKintor also mentioned an update on the US phase 2 trial of pyrilutamide/KX-826.
- The US phase 2 trial of KX-826 in male AGA completed enrollment in August 2022 and the company expects to release top line data in Q2 2023.
- Kintor Pharmaceutical plans to release top line data from its phase 3 trial in China in Q4 2023 and potentially follow with a new drug application.
Phase 3 Has Begun in China: Update (1/2/22)
On January 2, 2022, Kintor Pharmaceutical announced that the first male subject has received a dosing in their phase 3 pivotal trial of pyrilutamide. The phase 3 trial of pyrilutamide in male androgenetic alopecia will include:
- Randomized, double-blinded, placebo controlled parameters
- 416 male trial subjects
- A duration of 24 weeks/6 months
- A primary endpoint of change in number of non-vellus target area hair count from baseline to week 24
Kintor remains ambitious in thispress release, which has become their M.O., and states that they intend to complete this trial by the end of 2022. Dr. Youzhi Tong, CEO of Kintor Pharma, had this to say: “We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation（6 months study + 1 month follow-up）within the year. With the goal of completing the phase III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible.“
While it is still slightly odd that the phase 3 trial has begun before the full phase 2 data was released to the public, the initiation of a phase 3 trial must be a good thing. We can be sure the phase 2 data will be released shortly.
Kintor Receives Clearance For Phase 3 in China: Update (11/24/21)
Just at the heading states, Kintor has officially received the “go ahead” to begin a phase 3 trial of pyrilutamide by the NMPA (equivalent to FDA) in China. The pivotal trial which could lead to market approval in China will comprise 416 male participants who will be studied over a 6 month time period. Full details onthe announcementcan be found on Kintor’s website.
我n regards to the original premise of this article, that Kintor would begin a phase 3 trial in 2021, it appears that they are sticking to that timeline and are only off by a month or so. Let’s go Kintor.
A recent presentation from the Chinese pharmaceutical company Kintor suggests a rapid development plan for its androgen receptor antagonist drug pyrilutamide.
Below is a slide from Kintor’s August 25th Interim Results Presentation which outlines the company’s program for pyrilutamide, a topical androgen receptor (AR) antagonist drug also known as KX-826.
As you can see, pyrilutamide is currently being trialed for the indications of androgenic alopecia as well as acne vulgaris. We’ve seen this pattern before with the AR antagonist drug clascoterone/Winlevi (aka Breezula in 7.5%) which has been approved by the FDA for the treatment of acne by the US FDA and is preparing to enter a phase 3 trial for male pattern hair loss. Most of the information on the slide above is typical market validation statistics that companies like to present to shareholders, however, one detail stands far out from the others. Between the two highlighted red arrows you’ll notice the statement “Conduct MRCT (multi-regional clinical trial) phase III clinical trials in China and US in 2021.” I believe this is the type of checklist item that my audience is looking for. It’s almost extraordinary that a company could conduct a phase 1b trial for a drug in one year and go into a phase 3 trial in the next year, but apparently Kintor has a strategy. Their plans are made clear on the presentation slide and as a publicly traded company their public communications are held to high standards. In a previousarticle, I’ve discussed one possibility of how Kintor could make the jump from phase 1 to phase 3 in the US so swiftly.
The above image of Kintor’s pipeline displays a phase 2 trial of pyrilutamide currently underway in China with a notation stating the trial is “expected to complete patient enrollment in 2020.” This would point to the trial being completed somewhere around the end of Q1 2021, perhaps in the month of April. Stay tuned.Also interesting, according to Kintor,datafrom the US phase 1b trial of pyrilutamide is to be released in Q4 2020. Lastly, females may want to keep an eye out for this drug, because even though it has not yet been indicated for female AGA, the drug is similar to clascoterone/Breezula which we know is being trialed specifically for female hair loss. Let’s hope for good things from Kintor over the next several months.
What do the readers think of this intriguing announcement from Kintor Pharmaceuticals? Comment below to share your feedback.