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Hope Medicine Prolactin Receptor Monoclonal Antibody (HMI-115) for Hair Loss

HMI-115 is a human monoclonal antibody drug being developed by Chinese company Hope Medicine for the treatment of androgenetic alopecia (male and female pattern hair loss).

In November 2021, Hope Medicine received FDA approval to start Phase 2 clinical trials of HMI-115 for androgenetic alopecia. In 2020, the FDA also approved Phase 2 trials of the same drug for endometriosis. Phase 2 clinical trials of HMI-115 for hair loss are due to begin in the USA soon.

In Australia, Phase 1 trials are currently underway. The trial is due to last 6 months, with 20 participants receiving injections every 2 weeks (12 injections total).

Since November, one of the participants in this Phase 1 Australian trial - a 37-year-old man with the Reddit username moeman32 - has been posting some details of his experience to Reddit.

Here are some key quotes from his first post in early November 2022:

"My partner (female 46) and I (male 37) have started the trial. its a 6mo course, and we are 1mo in, having had two doses of the prolactin blocker, i buzz cut my hair and found that my hairline had moved forward by an inch, and at the fortnightly checkup found that it had actually started new growth."

I wont be posting pictures because I'm not sure if i should even be posting this much, as we are participants in the drug trial, but I will be happy to follow up with what I can. the process is they take our bloods weekly, but the doses are two needles, one on either side of the torso (much like diabetes meds) and is quite simple. I have had all my vitals and stats taken.

"It seems promising, and I am having no side effects that i can feel."

- moeman32 on Reddit

It gets better, though. Here is an update after his 4th dose:

Today is milestone one and I will be rephotographed and able to be shown my hair growth. There is already baby hairs showing further along my hairline to the front, just with the visible eye.

The vortex has filled out much thicker and quicker but that was existing hair, whereas the front scalp is now growing dormant hair. If I had to describe it, the hairline has definitely moved 15mm forward and the hair is a few cm long (havent had a haircut since before the trial)

- moeman32 on Reddit

The most recent update can be seen here after his 8th dose, and the hair regrowth continues:

So the best way to describe it, is like moss. Its growing thicker where the hair was, and creeping slowly but surely into the bald space where there is new hair. It is visually perceptible. Hairline has definitely moved forward as previously discussed .

In the follicle close up where they shaved a cm2 and use a macro lens, there is obvious difference between the original day 1 and this weeks photo. The best way to describe this is the hairs that were in the day 1 photo were translucent and thin whereas theyre getting thicker and darker and more opaque in the mid way photo.

So to add to this, more hair per follicle too, so where there was 1 or 2, its now 2 or 3 per pore, and in the spaces in between new hairs have started cropping up, so good news there too.

- moeman32 on Reddit

The Australian Phase 1 trial is due to be completed in July 2023. You can follow Hope Medicine's pipeline for this drug here.

HMI-115 was originally developed by a German company, Bayer AG, who hold the patent (WO2019011719A1) for this prolactin receptor antibody. Hope Medicine have a licensing agreement with Bayer AG to develop and commercialise this monoclonal antibody therapy.

The treatment has a somewhat unusual mechanism of action in that it works by targeting the prolactin receptor. This is unusual because androgenetic alopecia is usually blamed on the hormone dihydrotestosterone (DHT) instead.

However, the evidence so far suggests this mechanism may be fruitful. In addition to moeman32's Reddit posts above, an earlier study using monkeys reported great results too:

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.

- 2019 Hope Medicine press release