Pelage Pharmaceuticals Raises $16.75 million and Phase 2 Trials to Begin in 2024

Pelage Pharmaceuticals
Pelage Pharmaceuticals Logo.

I previously wrote about Pelage Pharmaceuticals in my 2019 post  related to the research of its President and co-founder Dr. William Lowry. The other co-founders are Dr. Heather Christofk and Michael Jung. I also covered the findings of Dr. Lowry and Dr. Christofk’s UCLA team in a 2017 post.

These UCLA researchers discovered two topical compounds (RCGD423) and (UK5099) that regrew hair in mice via different mechanisms. Both drugs involve an increase in lactate production. This in turn activates hair follicle stem cells and leads to increased and quicker hair growth.

Dr. Lowry’s patent can be found here. Patent and technology rights to both topical drugs have been exclusively licensed to Pelage Pharmaceuticals by UCLA.

Pelage Pharmaceuticals Raises $16.75 Million and Phase 2 Trials to Begin in 2024

February 27. 2024

Great new update (h/t “YoYo”). Pelage Pharmaceuticals has raised $16.75 million in Series A Financing. More importantly, they will begin Phase 2 Clinical Trials for PP405 in mid-2024.

Phase I clinical data met primary safety endpoints. And they confirm that their was statistically significant stem cell activation in hair follicles after just one week of treatment with PP405.

Per CEO Daniel Gil, Ph.D.:

“Our scientific co-founders have uncovered a unique biological mechanism with the potential to reactivate hair growth in people with alopecia.”

The company will present translational data at the American Academy of Dermatology meeting in March 2024.

February 17, 2024

Earlier today, reader “Ben” made an very interesting discovery on Pelage Pharmaceuticals’ website. The following sentence at the bottom:

“Early Phase I clinical data shows statistically significant stem cell activation in the hair follicles after one week of treatment with PP405.”

This is super news. So their trials have started. I wonder if PP405 is RCGD423 or UK5099? Their website homepage describes PP405 as:

“A novel, non-invasive, topical small molecule drug platform that activates stem cells in the hair follicles directly to stimulate robust hair growth. By targeting an intrinsic metabolic switch in hair follicles, Pelage’s platform is suitable for all genders, skin types, and hair types.”

In other recent news, Pelage appointed Dr. Qing Yu Christina Weng as Chief Medical Officer.

RCGD423

RCGD423 activates the JAK-STAT signaling pathway, which in turn leads to an increase in lactate production. This extra lactate activates hair follicle stem cells and results in quicker hair growth.

UK5099

UK5099, blocks pyruvate (a glucose metabolite) from entering cell mitochondria. This also results in an increase in lactate production in the hair follicle stem cells, and therefore accelerates hair growth.

OrganTech Aims to Regenerate Hair and Teeth

Update: February 23, 2024

More great news. OrganTech (Japan) is entering the South Korean market. Their local partner OrganEcoTech will get exclusive rights to OrganTech’s artificial organ regeneratice medicine technology, including hair growth. They also plan to enter the US regenerative medicine sector.

OrganTech and OrganEcoTech
OrganTech (Japan) and OrganEcoTech (South Korrea). New partnership.

Update: February 20, 2024

OrganTech CEO Takashi Kondo Interview

A new interview with OrganTech CEO Dr. Takashi Kondo (h/t “Theo”). Key quote:

In terms of hair regeneration, the future is just around the corner where people who suffer from thinning hair or alopecia will no longer have to worry about it.

He also says that they can increase the number of hairs from 200 to 20,000 via Dr. Tsuji’s autologous hair multiplication process. Hair and teeth regeneration remain their primary areas of focus. He also mentions the progress in artificial skin regeneration technology and and his desire to see a world without the need for animal testing.

The company currently only has six employees. Five researchers at RIKEN in Kobe; and one (himself, the CEO and person in charge of business and finance) in Tokyo. Per the news below from earlier this month, OrganTech will hire and additional six new scientists by summer.

They are being approached by many pharmaceutical and beauty industry companies for partnership opportunities. Ultimately, this will translate into faster fundraising, ecomomies of scale and a lower final cost of treatment.

Update: February 16, 2024

Reader “Theo” regularly e-mails me very unique info from Asia that I would never have found by myself. I could not get the second link below to translate properly, but I trust what “Theo” said. So I am pasting his words in the below three bullet points with minor grammar changes by me.

As always, Dr. Takashi Tsuji sounds very sincere. In the first link below, read his recollection of the two big tragedies at RIKEN. OrganTech seems very focused and is unlikely to repeat the past fundraising related mistakes from the Tsuji team.

OrganTech and Dr. Tsuji from Riken.
Dr. Takashi Tsuji of RIKEN presenting to university students recently. His hair and teeth regeneration work is now undertaken via OrganTech.
  • Dr. Takashi Tsuji gave an interview and presentation to a Tokyo University student group two months ago. They visited his very expensive lab and he explained to them his vision about OrganTech’s future. They got far more funding that they need, from several different companies. Their vision is to make OrganTech an off-shore company for groundbreaking research from different scientists who are looking for funding.
  • Dr. Tsuji plans to create a consortium that could be called a “second RIKEN” by establishing companies for each business to socially implement regenerative medicine technology, with OrganTech at its core.

Two Part Interview and Presentation

https://note.com/utdiligent/n/n78bd096e3ab5

https://note.com/utdiligent/n/n7fce80d6710f

  • OrganTech is hiring 6 new scientists by the end of April 2024. After June, they will move to new offices and a research center in the Harumi neighborhood of Tokyo. It seems like they may start clinical trials around that time for both hair and teeth per “Theo” (I could not find anything on trials in the translation I got). Their artificial skin business is also advancing.

https://jp.indeed.com/viewjob?jk=6ce284d70b0a789f&tk=1hmpusbgu2b1p002&from=serp&vjs=3

Update: June 29, 2023

OrganTech Miho Ogawa
OrganTech and its CEO Dr. Miho Ogawa win a prestigious award in Japan.

OrganTech Wins Future Award 2023 for its Organ Regenerative Medicine Technology

Congratulations to Dr. Miho Ogawa of OrganTech for winning Japan’s prestigious “The Economist Future Award 2023“. Per my new Japanese correspondent (old ones were “nosyu” and “Fuji Maru“), this award is sponsored by the “Economist Future Awards 2023 Executive Committee” and supported by the renowned Mainichi Shimbun newspaper agency. There were 225 nominated companies, of whom 15 got awards spread across 5 categories. Dr. Ogawa only became CEO/Director of OrganTech in early 2023.

Make sure to read the detailed interview with Dr. Miho Ogawa that I also posted earlier this month. She started working at Dr. Takashi Tsuji’s lab in 2005 at the Tokyo University of Science when she was a student. Thereafter she joined Organ Technologies, which folded in October 2020 due to fundraising issues that were exacerbated by the Corona crisis.

Now she is back with OrganTech, and I am getting positive vibes yet again for Dr. Tsuji’s hair multiplication work finally reaching fruition. The prior issues with fundraising inexperience and surprise pandemic will surely not be repeated. Japan is home to one of the oldest populations in the world, and also home to one of the fastest clinical trial processes in the world. Especially when it comes to regenerative medicine and anti-aging treatments.

Make sure to keep checking OrganTech’s website for new developments. Per my prior updates, they are aiming to start hair regeneration related human clinical trials in 2024. And they want to offer their hair multiplication treatment in clinics in 2026. I assume they can move this fast due to their past decade of work combined with Japan’s favorable regulations. However, as most readers know, their original goal had been 2020, prior to the earlier mentioned disruptions.

Update: June 1, 2023

Japan: Global Hub for Hair and Tooth Regeneration

An interesting new interview with OrganTech’s confident representative director Dr. Miho Ogawa. It looks like the team is very serious about making Japan the global hub for hair and tooth generation. And they are keen to avoid repeating past fundraising and commercialization related mistakes.

The other representative director is Takashi Kondo (see his recent interview), who is in charge of business planning and fundraising. Ms. Ogawa is in charge of research and development and technology.

Lead scientist and OrganTech owner Dr. Takashi Tsuji remains fully involved of course. The company is scheduled to conduct clinical research within one to two years for practical application. With Japan’s fast track regulations, this treatment could still get to clinics in 2026 as was announced by Dr. Takashi Tsuji last year. Key quote:

“In the near future, this world-first, Japan-originated organ regenerative medicine management will shock the world and contribute to improving the QOL of many people.”

Tsuji Mouse Hair OrganTech
Human hair growing on mice via the work of Dr. Takashi Tsuji and his team at RIKEN.

Update: February 11, 2023

OrganTech: New name for Organ Technologies

Organtech
Organtech: hair follicle and other organ regeneration technologies.

After ending its partnership with Riken and Dr. Takashi Tsuji in 2021, Organ Technologies is back. It is renaming itself to OrganTech, and this time the founder himself is Dr. Tsuji. A little confusing, but read the next paragraph. OrganTech plans to start hair regeneration related clinical trials in 2024. And yet again they have a new website. They are also getting funding from Kobayashi Pharmaceutical.

According to the latest press release, it seems like founder Dr. Tsuji will remain the team leader and OrganTech is still affiliated with RIKEN. However, Dr. Tsuji cannot be officially titled CEO, since RIKEN does not allow its top scientists to be CEOs of venture firms. This last point was e-mailed to me by a reader.

I previously mentioned how Dr. Tsuji took over Organ Technologies’ debt in 2021 in order to prevent patent loss. He also announced that they plan to offer their hair multiplication treatment in 2026. So this new development means they are on schedule. Note that Japan has favorable regulations in relation to clinical trial speed when it comes to regenerative medicine.

They are also very serious about fundraising this time. On March 6th 2023, they plan to present their technology on Tokyo Innovative Business Day. On OrganTech’s website, it says that the company’s purpose is to “create functional organs.” They they emphasize the two main areas of Dr. Tsuji’s past work:

“Technologies that can contribute to hair regenerative medicine and dental regenerative medicine.”

Also of interest, the following patents are assigned to Organ Technologies. These now belong to OrganTech.

Jan 5, 2020

I have mentioned many times that Dr. Takashi Tsuji and his hair loss treatment protocol holds the best short-term prospects for a hair loss cure. Mr. Tsuji is working in partnership with RIKEN, Organ Technologies and Kyocera. The treatment can come to market faster because 1) It is autologous in nature; and 2) Clinical trials in Japan get finished faster due to favorable government regulations.

All four of these Japan-based partners have their own sites (in Japanese and English). So it is hard to keep a track of new developments.

Organ Technologies and Takashi Tsuji

Organ Technologies has updated its website (Update: They replaced it yet again with a new one in 2023. See upper sections of this post for latest updates). A goldmine of information is available on the new site.

The hair regeneration page has a list of publications at the bottom. Apparently, the company has developed three generations of its technology over the years. Mostly via the work of Dr. Takashi Tsuji and RIKEN (in Kobe, Japan).

I will add more to this post in the coming days, but wanted to start the discussion now. Please only post comments about Organ Technologies and the work of its partners in this post.

Organ Technologies Hair Regeneration Treatment.
Organ Technologies Hair Growth.