HMI-115 Begins Phase 2 Trial In China
The long awaited phase 2 trial of Hope Medicine’s HMI-115 in androgenetic alopecia has officially begun.
HMI-115 Antibody Starts Phase 2 Trial
It has almost been two full years since Hope Medicine issued an exciting press release which announced the company’s approval to conduct a phase 2 clinical trial with the US FDA. Since then, Hope Medicine decided to pursue a phase 1 trial for HMI-115 in Australia which included both men and women. That phase 1 trial has since been completed, and during its course it created a bit of a spectacle on various message boards due to rumors about HMI-115’s positive efficacy being reported. Today, Follicle Thought is pleased to announce that a phase 2 trial of HMI-115 has indeed commenced., although still not in the US.
A new listing has been posted to the Clinical Trials website detailing the parameters of HMI-115’s phase 2 study. The important details are as follows:
- 180 male participants will enter the study.
- 24 week / 6 month treatment period for all participants.
- The phase 2 trial began September 2023 and is expected to complete by December 2024.
- The trial is randomized, multicenter, double-blind, and placebo-controlled.
- Primary outcome is the mean change in target area hair count (TAHC) of non-vellus hairs from baseline.
- Norwood scales 3 vertex, 4, and 5 will be accepted to participate.
- Four cohorts will be formed, including a placebo group, and three groups receiving HMI-115 injections of either 120mg once every four weeks, 240mg once every four weeks, or 240mg once every two weeks.
And just like that we’ve got another important hair growth drug at the phase 2 stage. It’s not immediately apparent what Hope’s strategy will be for female pattern hair loss in the future. As stated above, women were included in the phase 1 trial. Pending on how the treatment worked for females previously, Hope Medicine could still initiate a phase 2 trial for women in order to pursue approval for female pattern hair loss. For now, Hope Medicine’s plans to begin a phase 2 trial in the US are still unclear. It seems as though a trial could be initiated at any moment, or could come after the trial in China is complete.
At the end of this newly announced phase 2 trial it can be expected that the world will finally get some official efficacy data from HMI-115, which will help put some wondering minds at ease. It’s quite possible that the trial will be completed by Q3 2024, and that topline data may come before next year’s end. Let’s see how it goes for Hope Medicine. Recently, the company also announced a business development with Chime Biologics for the scaling-up and manufacturing of its monoclonal antibody drug HMI-115.
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Posted in Hope Medicine HMI-115
Thanks to john doe for the tip!
I feel like the news and developments are really progressing at this year’s end.
And for those who are not following the Updates page (it’s a good idea to check it often) here is some bonus news about a new oral medication coming out for androgenic alopecia.
https://folliclethought.com/updates/veradermics-doses-first-patient-with-new-oral-hair-loss-drug/
Thanks FT, is this VDPHL trial ph1 or 2 though? The press release says FIH, which suggests ph1, but the website pipeline page indicates ph2….
Thanks LJ, I shared in the Update I linked to that I believe it’s a phase 2 trial. This is based on their website pipeline. I agree, it’s not clear how they got to jump to phase 2 at this time. I hope to shed some light on that in the near future.
Is it possible that Hope Medicine Takes the results of the China Phase II trials for applying in EU or US for Phase III trials? So i would like to know whether the have to be Phase II trials in EU/US or Can they be skipped of Hope Medicine Presents the Phase II results of china?
Karl, I believe that type of path is possible. I’m not sure if Hope is going that way, but I have heard that it has been done with other drugs before. In the case I heard, the phase 2 trial was carried out in Australia.
Nice work FT as usual! Btw did you hear about a new company called Concert Pharmaceuticals? https://www.thedailystar.net/life-living/news/drug-cure-bald-hair-here-scientists-claim-3034421
Thanks Yoyo. I’ve covered Concert Pharmaceuticals several times before. Their drug is for AA, and that article is intentionally misleading by the looks of it.
Isn’t it already in Phase II trails for the other purpose? (Endo-something for women)
I think it might be, Yak, I’m not sure. Will take a look.
Update: Yes, it appears to be at phase 2, not sure how easy it would be used off-label if it becomes approved sooner for a different indication like endometreosis, but it may still be a possibility as I imagine you are alluding to.
So if I read this correctly HM-115 can grow terminal hairs in bald areas?? So this will grow permanent hairs if the human trials are successful?
Tony, we don’t know exactly until we have a better look at human data.
Hi FT, I was wondering if you were going to add Yokohama to your “ULTIMATE GUIDE TO HAIR REGENERATION PIPELINE 2023”?
YoYo, yes as soon as I have some spare time, will update the guide pipeline completely.
Perfect, thank you
https://www.wionews.com/science/scientists-achieve-major-leap-forward-to-potential-hair-loss-cure-660474
Thanks for sharing YoYo. I also saw this when it was published.
Hello! And what about HMI115 for women? In theory, prolactin is more influential on hair loss in women… Is nothing known about the results of phase I?
Hi Peladillo, no nothing regarding efficacy has been officially shared from the phase 1 trial. The future for HMI115 in females remains open-ended.