Hope Medicine Announces Phase 1b Results for HMI-115
Positive news to start the new year with Hope Medicine’s HMI-115 Phase 1b results announced on January 14th, 2024.
Successful Results for Male Participants
Hope Medicine has released positive data from their Phase 1b trial conducted in Australia titled, “An Open-Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period”. Details and results from the completed trial are as follows:
- The Australian Phase 1b AGA trial included 12 male and 4 female participants.
- Male subjects who met Norwood-Hamilton scales 3v, 4, and 5 were included.
- Female subjects who met Sinclair scales 2-4 were included.
- All participants received the treatment (240 mg) once every 2 weeks via subcutaneous injection.
- Mean non-vellus target area hair count (TAHC) was measured at the baseline and endline.
- The TAHC increased by 14 hairs/cm2 compared with baseline after 24 weeks of treatments, which was statistically significant.
- The treatment was also reported to be safe and well-tolerated, with no details provided of adverse events.
What About the Female Participants?
There were no data released for female participants. As there were only four women included in the study, there are unlikely to be any statistically significant differences.
Recruitment for Phase 2 Trials Underway
These encouraging results have led to the recruitment of a Phase 2 study, which will be conducted in China with 180 participants.
What are your thoughts about these results? Share them in the comments below.
Thanks for sharing. 14 hairs/cm2 might be statistically significant, but how noticeable really would that be? Also wonder how practical this treatment is, assuming a patient would continue losing hair at the same time.
14 hairs/cm2 won’t make a huge difference visually.
The patient will continue to loose hair 6 months after the injection when everything is out of the system.
You’ll need treatment every 1-3 years for maintenance depending on how aggressive your hairloss is.
Phase 2 will show how effective it really is since Phase 1 had no placebo. If placebo group has some growth like it has in many studies than this would make the 14 hairs/cm2 even less promising.
It might get scrapped after Phase 2 and never hit the market but at the end I still have some hope because it could be a new weapon to add to the arsenal.
Why do you say that after 6 months you lose your hair? You have no idea what you’re talking about. You should read more about HMI before making these statements. It had sustained effect on those monkeys even after 2 years+ post treatment and also that guy who was in trials confirmed that even at this moment his hair continues to grow in previously bald areas.
Six-month terminal hair count endpoints aren’t always great predictors of what might occur for any hair loss treatment at year 1, 2, 3, etc. In the case of minoxidil, hair counts peak after 4-6 months of use, then decline thereafter. In the case of finasteride, hair counts peak after 24 months. Will HMI-115 produce a regrowth trajectory similar to minoxidil… or finasteride? Will that 14 hairs/cm2 number increase… or decrease? I’m looking forward to finding out.
Nice work FT as always! Things seem to be coming along slowly but surely, it’s a little disappointing as we still haven’t had an update from Pelage. I thought by now we’d get something, but I am excited for Amplifica’s first trial completion in March.
Is 12 participants common?
Anything new coming out in 2024?
This treatment is subcutaneous injection in fat or in belly fat?
So HM-115 grew brand terminal hairs in bald areas? Via injection? Will more women be included in the next phase?
I don’t think it showed any effect in women
14 haren per vierkante centimeter is vrijwel niets