Hair Loss Cure 2020

Mallia Therapeutics (formerly MalliaBioTech) is a Germany-based company that is developing a novel hair loss treatment based on a soluble version of the CD83 protein.

Update: May 28, 2025

Mallia Theraputics: 8T3 for Hair Regeneration

It seems like Mallia will soon release two cosmetic hair loss products that are based on the ingredient MAL-838 (a formulation of the soluble CD83 protein):

8T3 Essentials for at-home use.
8T3 ProLine for profession use.

Note that they also have a page on MAL-856, which is described as “a structural variant of the extracellular domain of the membrane bound form of CD83 (mCD83).” Both alopecia areata and androgentic alopecia are mentioned on that page.

It is a bit unclear whether the company still plans to conduct clinical trials and release a stronger non-cosmetic product in the future.

Also of note, Mallia Therapeutics will participate at the 2025 annual meeting of the European Hair Research Society (EHRS) in Warsaw, Poland from May 29 to 31. Their presentation is titled “Soluble CD83 as a novel therapeutic approach for the treatment of alopecia.”

Update: February 4, 2025

Mallia Therapeutics and Northway Biotech (Lithuania) have announced a partnership for the development of the production process and manufacturing of Mallia’s soluble CD83 protein (sCD83). Northway is a biologics Contract Development and Manufacturing Organization (CDMO) with facilities in the US and Lithuania.

Update: June 18, 2024

Mallia Therapeutics expects to start 150-person clinical trials at the beginning of 2025.

Update: July 11, 2023

Mallia Therapeutics Secures Seed Funding

Mallia Therapeutics (previously MalliaBioTech) finally has a website. Moreover, the company just announced that it has secured seed funding. They now plan to raise Series A funding prior to beginning clinical trials.

The company is developing a soluble CD83 (sCD83) based topical treatment of hair loss.

This sCD83 has an immune-modulatory function and induces hair growth via a dual mode of action:

It induces an anti-inflammatory environment around the hair follicles via regulatory T cells (Tregs). These interact with follicular stem cells and activate hair growth.
It directly binds to follicular stem cells and induces the formation of new hair follicles. So sCD83 not only prevents hair loss and accelerates growth, but also induces the growth of new hair.

Moreover, this treatment will supposedly work for both androgenetic alopecia (AGA) and the less common alopecia areata (AA).

Key quote (slightly reworded):

“The company is led by world leading experts in the field of CD83, with more than 60 CD83-related publications and 20 years of relevant experience.”

November 4, 2021

A new biotech company in Germany named MalliaBioTech is working on a topical hair loss treatment based on the CD83 molecule. Thanks to “Marcus” and “James” for sending me several of the below links.

Mallia Biotech, CD83 and Hair Loss

On October 27, the Friedrich-Alexander University (FAU) in Germany published an important page on their site titled:

“FAU project wins funding for remedies against hormone-related hair loss.”

An soluble CD83 based active ingredient newly developed at FAU leads to new hair growth. The FAU researchers from the Department of Immunomodulation and the Department of Dermatology at the University Hospital Erlangen received the m4 Award for this project on October 21, 2021.

So far, this CD83 (see gene card) based active ingredient has not shown any side effects in pre-clinical studies.

Mallia Therapeutics CD83 Hair Growth — CD83 hair growth before and after. Screenshot from a Mallia Biotech video.

The research team is led by Dr. Alexander Steinkasserer, who I e-mailed for more information. His co-researchers include Dr. Dmytro Royzman and Prof. Dr. Carola Berking. Their new company is called MalliaBioTech, and it received EUR 500,000 via the m4 Award. It is officially called the m⁴ Award from the state of Bavaria.

“The new product has the potential to conquer the large unfulfilled market of hair loss.”

In contrast to existing hair loss treatments Finasteride and Minoxidil, this topical treatment based on a soluble form of the CD83 molecule:

“Stimulated the formation of new hair follicles and thus induces new hair growth.”

While the current pre-clinical work is in mice and yet to enter human clinical trials, this research represents yet one more new method to tackle androgenetic alopecia. We read about at least five such major new hair loss cure related discoveries every year, so reader skepticism is warranted.

When I first heard about CD83 for hair growth, I assumed it would be for alopecia areata. This is due to the frequent use of the word “immune” in tandem with CD83. However, the new German research clearly indicates that this treatment will also work for hormonal hair loss (aka androgenetic alopecia).

Read the bottom half of this post for my original report on Hope Medicine (China)’s HMI-115 (licensed from Germany’s Bayer). New updates are on top. This treatment targets the prolactin (PRL) receptor to cure hair loss. Hope Medicine raised $56 million in funding in 2021. See their pipeline page for more information.

The initial reason for all this excitement was due to the spectacular long-lasting hair growth results seen in stump-tailed macaque monkeys. When I originally wrote this post in 2021, these monkeys were still being monitored and had not lost their hair even over four years after stopping prolactin receptor antibody treatment.

Prolactin Hair Growth (Hope Medicine HMI-115). — Hope Medicine and Bayer prolactin receptor antibody (HMI-115) hair growth. Before and after in stump-tail macaque monkeys. The hair growth has remained even years post treatment cessation.

Update: May 25, 2025

Hope Medicine’s HMI-115 could get Released in 2027

I did not update this post for over a year in spite of the significant interest. Recently, “Theo” sent me a link to a detailed December 2024 interview with Hope Medicine’s founder Rui-Ping Xiao (also called Xiao Ruiping). The part that stood out:

“Xiao revealed for the first time in the program that the drug they developed for the treatment of hair loss has completed the second phase of clinical trials and will be available globally as early as 2027!”

So this must be the 180-patient Chinese Phase 2 trials that are completed (they began those in 2023). The results must have been very promising for Dr. Rui-Ping to be so confident about a product release in 2027? And maybe Phase 3 trials have already started?

The delayed US Phase 2 trials likely never started, and perhaps they are not moving forward with Phase 2 trials in Australia either (after conducting successful Phase 1 trials there)? I have not checked out any government clinical trial pages, but perhaps readers can chime in. Dr. Rui-Ping also gave an important video presentation in December 2024, and she seems like the real deal.

Watch this video on YouTube

Update: January 14, 2024

Positive Outcome for HMI-115 in Phase 1b Study in Australia

Really excellent news to start of 2024. The Phase 1b study for HMI-115 in Australia showed positive results in terms of efficacy and safety. The study included 12 males and 4 females. It seems like “moeman32” from Reddit was not lying and I am glad that I covered him for months in my earlier updates despite his erratic behavior. Key quote from this latest press release:

“Specifically, in the 12 male patients at the end of the trial, the mean non-vellus target area hair count (TAHC) increased by 14 hairs/cm², compared to that of the baseline. This increase is statistically significant.”
“This study is the first ever to show that prolactin receptor blockade can promote hair growth in patients with androgenic alopecia and may provide a novel therapeutic approach.”

We also got an update from CEO Nathan Chen (who seems to have replaced Henri Doods?) that the Chinese Phase 2 trial recruitment of 180 patients is ongoing. A bit slow considering that they started this process in August 2023. It seems like they were awaiting the final results of the Australian trial before proceeding further in China. They aim to achieve full PoC (proof-of-concept) by the end of 2024. No updates on the delayed Phase 2 US trials.

Update: October 27, 2023

Hope Medicine and Chime Biologics Enter Manufacturing Agreement

Hope Medicine (China) and Chime Biologics (China) have partnered to “speed up” the manufacture of the first-in-class monoclonal antibody drug HMI-115. Chime Biologics is a leading contract development and manufacturing organization (CDMO). The two companies are committed to commercialization of HMI-115 for the treatment of both androgenetic alopecia and endometriosis.

Update: August 1, 2023

Phase 2 Trial Recruitment Begins in China

The HMI-115 Phase II clinical trial recruitment for androgenetic alopecia in China has now started.

Encouraging Updates from Australian Phase 1 Trial Participant

A November 2, 2022 detailed Reddit update from an Australian trial participant (HMI-115 dose 1 and dose 2) is required reading. This 37-year old male described in detail his first two doses of the prolactin blocker via injection. He (along with his 46-year old female partner) will get treatment every two weeks for six months. So a total of 12 doses, all at Sinclair Dermatology in Melbourne. Note that while these are Phase 1 trials in Australia, the same HMI-115 product is scheduled to undergo Phase 2 clinical trials in the US anytime soon.

This Reddit user “moeman32” seems legitimate and has a posting history of over ten years. He has also written about Australia many times in the past. He will do follow-up posts every two weeks. Note that all 20 patients in this Phase 1 safety trial are getting the actual drug injected. i.e., no placebo participants needed to test for efficacy this time around.

Update February 8, 2023: Unfortunately, he had to remove his posts due to some stalker issue. But the below threads have as yet not been deleted.

The beginning (dose 1 and dose 2).
First follow-up (dose 3).
A really encouraging second follow-up (dose 4).
Third follow-up (dose 5). Another positive update.
Fourth follow-up (dose 7). Seems like there was a miscount in dose numbers and we added one. In any event, I have no reason so far to doubt this person’s honesty.
Fifth follow-up (dose 8). Perhaps the most encouraging one to date! Just in time for Christmas.
Sixth follow-up (dose 9). They showed before and after photos for the first time.

Update: April 12, 2022

The Australian Phase 1 trials for Hope Medicine’s HMI-115 are starting today. They will involve 20 participants and are expected to be completed in July 2023. The trials will be led by the renowned hair loss expert Dr. Rodney Sinclair. And there is lots of excitement on Reddit.

Meanwhile, US Phase 2 trials should start at any moment now (read further below). This difference in trial progression by country is strange. Perhaps is has to do with some stricter Australian government requirements.

Update: January 26, 2022

Hope Medicine HMI-115 US Phase 2 Trials

Hope Medicine just received FDA approval to commence Phase 2 clinical trials in the US for its HMI-115 product to treat androgenetic alopecia. HMI-115 is a human monoclonal antibody drug that targets the PRL receptor for the treatment of male and female pattern hair loss. Last year, the US FDA also approved Phase 2 trials of the same drug to treat endometriosis.

The Phase II clinical trial of HMI-115 for the treatment of androgenetic alopecia:

“Will be an international multi-center, randomized, double-blind, placebo-controlled study. It will be carried out in the United States, Australia and other countries.”

May 9, 2021

Hope Medicine Raises $56 Million

Recent excitement in the comments of this blog revolved around Kintor Pharmaceutical (China). However, this weekend, the participants on this site’s hair loss chat are discussing Hope Medicine (China). Out of the blue, this startup company received $56 million in a Series B round of financing. Investment firms Qiming Venture Partners and Grand Flight Investment led the way.

Key quote:

“Previously, HopeMed signed an exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and will soon be launched.“

Other investors include: HighLight Capital; Sinovation Ventures (a venture capital firm led by former Google China head Kai-Fu Lee); and Trustbridge. More here.

HMI-115 PRL Receptor Targeting: Bayer License

Note that I first covered Hope Medicine in my 2019 post on its partnership with Bayer in regards to the prolactin receptor. The company was founded by Dr. Rui-Ping Xiao, the dean of the College of Future Technology of Peking University. Apparently, she is also an associate editor of the New England Journal of Medicine. See this page for much more on Dr. Xiao Ruiping.

The most unusual part of this story is that Hope Medicine’s official website has not worked for weeks.

Update: November 28, 2021

New Interview with CEO Henri Doods

There is a cover page listed interview of Hope Medicine’s CEO Dr. Henri Doods in a Chinese magazine “tradetree.cn”. If anyone can gain access to it and translate it into English, please try.

(Update: As of 2024, Hope Medicine has a new CEO called Nathan Chen).

Per reader “Karl”, Phase 2 clinical trials for hair loss product HMI-115 are planned for Q4 2021 (but no proof anywhere else). This matches what we expected per the prior updates that I discussed. Note that HMI-115 is the same as Bayer’s prolactin receptor antibody. Hope Medicine has the rights to the development of this product.

Update: A reader sent me the below screenshot of Hope Medicine CEO Henri Doods’ Chinese magazine interview that I mentioned earlier. If anyone can translate it into English, please post in the comments. Click on the image to expand.

Mallia Therapeutics, CD83 and Hair Loss