Hope Medicine Gets Approval For Phase 2 Hair Loss Trial Of HMI-115
HMI-115 Phase 2 Trial Begins In China: Update (11/7/23)
Just under 2 years since this original article was published, Hope Medicine has officially launched a phase 2 clinical trial for HMI-115 in China. The study is listed on ClinicalTrials.gov and the actualy start date of the trial was in September 2023. Details are as follows:
- 180 male participants to be randomized into 4 study cohorts.
- The trial is expected to officially complete by December 2024.
- Three HMI-115 treatments groups include: 120mg injected once every 4 weeks, 240mg injected once every 4 weeks, and 240mg injected once every 2 weeks.
Original Article
Another important hair growth treatment has received IND approval to begin a phase 2 trial for androgenetic alopecia in the US in 2022.
HMI-115 Monoclonal Antibody Treatment For Hair Loss
On January 25, 2022, Hope Medicine issued a press release announcing that the US FDA has approved the investigational new drug (IND) application for their antibody therapy HMI-115 for the treatment of AGA or pattern hair loss. This means Hope Medicine is now able to begin a phase 2 clinical trial for AGA in the US. In today’s press release, Hope stated that its upcoming phase 2 trial in AGA will be an “international multi-center, randomized, double-blind, placebo-controlled study, planned to be carried out in the United States, Australia and other countries.” It was also reiterated that Hope Medicine will be pursuing the treatment of both male and female androgenetic alopecia with HMI-115, however, it is not clear if the first phase 2 trial will include both male and female subjects.
HMI-115 has grown in popularity with the online hair seeking community over the past two years due to comments that Hope Medicine made in an earlier press release regarding a preclinical study of HMI-115 which was carried out in a small primate model. At that time it was also disclosed that Hope Medicine had licensed the prolactin receptor antibody now known as HMI-115 from Bayer AG, a global pharmaceutical company well known for its sale of aspirin. The original quote of interest is as follows: “The antibody was effective in stimulating hair growth in aged stump-tailed macaques, nearly doubling the number of terminal hairs after 6 months even in previously fully bald areas and showing a sustainable impact even after 2 years post treatment. Notably, the stump-tail macaque model is considered one of the rare predictive animal models for male and female pattern hair loss in humans.“
This is one of the news items that was at the top of many people’s lists. We look forward to hearing about the first patient dosed in this important phase 2 study. Please share your thoughts in the comment section.
Posted in Hair Growth Treatment
How’s 2022 so far?
Thanks to multiple readers who were quick to alert me of this development.
Keep it up FT, came from behind HLC2020 and now he’s eating your dust
HLC2020 lost his touch. You can tell he became a victim to the negativity and has stopped reporting important research
I appreciate the support guys. I wish other sites well, I’m just focused on my work here.
Fingers crossed for this… After Follicum and especially Biosplice, I’ve learned to temper my expectations 🙁
Wise decision PJ
Feels good to see progress from many different companies.
Kintor, Stemson, dNovo and Hope Medicine have all got me catiously optimisatic.
Hopefully 2022 will be a good year and nobody plus a biosplice.
Amazing news! 2022 has me excited. The hair restoration industry is hot. More interested investors with deep pockets, the research is more advanced, the speed of clinical trials is happening faster, and serious competition will only continue to push the industry forward. I have the feels for sure. Thank you FT for creating this space for us, and for keeping us informed. So grateful for you Joseph.
thanks Elle
Thanks Admin! Do you know how long the trial will be? They still hide their pipeline and dont even have a running website.
I would anticipate a 4 month trial, but they haven’t said yet.
Best news of 2022! Thank you for always keeping us updated. Follicle Thought is the most up to date hairloss website on the internet with all the latest news for hair regrowth.
Very excited to see the results of this phase 2 as I find it to be the most likely treatment to seriously work and without side effects from all the treatments in the mid-short term pipeline.
Also, it’s great to see HMI-115 doing an international multi-center phase 2 trial. That’s almost as close as the confidence in their treatment as what Kintor is doing with their trials.
Would be awesome if we could find out which “other countries” the ohae 2 trials will be conducted in and how to go about applying to be part of the trial if it is in one’s country.
Also, if we could find out the date of the start of the phase 2 trial and how long it takes, that would be super.
So just like that, another company has already caught up with with Kintor in the USA. Both companies have been green lighted by the FDA for a Phase II trial. Yet, Kintor has not even started theirs 6 months later. They’re fast in China, but not the USA. Maybe Hope beats them in the USA market.
Both companies very interesting. Especially since Kintor got an IND for GT20029 in the US as well.
Hey FT how are you? I was wondering, if you had to guess, as to why it is taking so long for Kintor to release their Pivotal Results for Phase ll of pyrilutamide? As I believe they were initially wanting to release the results around end of December.
Kintor don’t release their results because they don’t want their stock to crash If they had some thing to show it would be out by now
Their Covid-19 result wasn’t great it affect their stock big time Luckily we have lot more companies to look up
You could very well be right about this reasoning Kapil.
I don’t think that was the case at all. The reason they said that the trial for proxalutamide didn’t show satisfactory results wasn’t because of the drug itself it was because not enough patients were enrolled and tried the drug, as well as not enough ranges of severity of COVID. That’s why they’re repeating the trials again with more patient enrolment. Proxalutamide is an AR Antagonist that affects the systemically hence I’m pretty confident that it causes sexual side effects, ED and other symptoms. However it’s taken for a short period of time until the Covid is treated. But Pyrilutamide doesn’t get absorbed systemically, its locally. Plus the half life of the metabolite is very short and hardly traceable in the blood (nanograms I believe). That’s why I’m confused because the results had shown no severe adverse side effects and the main side effect was dermatitis. Plus no patient had pulled out of the trial either. I’m looking forward to Pyrilutamide to use for a few years until something better is available like you said, (hopefully dNOVO or Stemson). Once Stemson receive series B funding for human trials, which I think is definitely a possibility this year, things could be looking up for us finally. dNOVO looks promising too as the stem cells they used on the mouse were strictly human.
If humans respond as well as monkeys, this is almost a cure, except if you were bald for 20 years.
Wow this year has been going great so far! Thanks for the update admin. If i am not wrong there are 3 more companies which promised to start clinical trial this year( Turn bio, Amplifica, eiron therapeutics)
What is eirion therapeutics?
Find the search bar within this site and type “eirion therapeutics”
Admin how much will this cost though?
Price is quite far down the road. It would be a prescription drug, so typically should be manageable on a monthly basis. Has anyone had insurance cover finasteride?
FT –
Have a thought for you – and I have a fairly strong conviction that you’ll want to explore this Plath, If you feel secure it it’s outcome. have you researched DAO’s, and how they democratize fundraising, etc? Most notably, a DAO backed my millions of individuals nearly purchased a copy of the constitution? Would love to chat with you about it if you’d like. I think this community could be converted… and be a contributor to the growth of a, or multiple, solutions. Those who would participate would be given first access to information and potentially trials – all within the boundaries and rules written within the DAO. Engagement would be super high…. And the publicity ……..(good for the industry)…. Worth a discussion piece, or maybe not. I’m glad to help but I think you should be the one running it – can explain why also. Well, let me know. The tech is there now, and I’m sure once you start thinking about the possibilities, with some unification, it could really act as an accelerator.
Just saying all this for the good of the community – it could be a major solution, in allowing people to reach their goals more quickly and efficiently, with the idea of providing more data that could be shared and utilized by all
Jon, thanks for this idea. Sounds very involved but I would like to hear more about this at the right time.
My doctor prescribed me Proscar for hair loss and it was covered by insurance. Until all of a sudden it wasn’t (after a year or so). I can only deduce that they saw that there was no enlarged prostate diagnosis, so they nixed it.
Thanks for the feedback Scottie. So, some finasteride for hair is covered by insurance companies.
Did they skip a phase I? Or did I miss something?
I think they did miss Phase 1 because of its effectiveness for Endometriosis. Could be wrong though.
I guess you are right, I’ve also read the sheet describing the side effects recorded on an Italian forum 😊
It seems that Dr. Fukuda has established a company related to hair regrowth.
Source?
That would be the best news of the year (so far).
https://www.ynu.ac.jp/hus/koho/27237/34_27237_1_1_211130013534.pdf
Japanese only
Thanks! I gave you a shoutout in the comment of the updated Fukuda article. I appreciate the info.
Could you email me buguan on Contact page? Or share a link.
I’m sorry for the continuous throwing
The company name is Tricho Seeds
It looks like China is really trying to storm the market!
The Cold War gave us space exploration and moon landing, will whatever-this-West-vs-China-competition-is give us the cure for baldness???🤣
One thing is for sure: a cure for alopecia will come one day! We hope, of course, that it doesn’t take too long.
Hi admin, I am confused as to why the potential treatment has been approved to begin phase 2 clinical trials in January but is now starting to conduct phase 1 trials in your latest updates page. Could you explain it to me? Thx 🙂
J., it’s not clear yet. Some readers believe that they are still going into Phase 2 in multiple countries, but Australia made them start at phase 1. So, we will have to see. It’s still possible that they go into phase 2 in US/EU.
Anytime I feel sad about my hair, I read this update that you had made about hope medicine being cleared for phase 2. Everytime I read the blue text and the efficacy it had in alopecia bearing primates I feel so much hope . Getting that type of density will free my mind from this horrible disease. Besides hopemedicine I don’t have any hope for other treatments in development right now (except stemson tx)
It has been a long time. There is no update about hmi-115.
Any idea about the progress? And what are their expect timelines for further road map?
[…] encouraging results have led to the recruitment of a Phase 2 study, which will be conducted in China with 180 […]