JW Pharmaceutical to Begin Clinical Trials in 2024

Update: May 20, 2024

A detailed summary with images can now be seen on the company’s website.

JW Pharmaceutical’s poster presentation at the recently ended US Society of Investigative Dermatology conference was a big success. The company’s WNT pathway activating hair loss product JW0061 caused a significant increase in the number of hair follicles compared to a standard-of-care drug.

  • Treatment of skin organoids with JW0061 caused the number of hair follicles to be 7.2 and 4.0 times higher on days 5 and 10, respectively, when compared to standard treatment.
  • Moreover, the results also showed a dose-dependent response. A low dose JW0061 treatment caused an 18% increase in efficacy. A high dose JW0061 treatment caused a 39% increase in efficacy.

Update: May 8, 2024

JW Pharmaceutical will present the preclinical results of its JW0061 Wnt pathway activating hair loss treatment in a poster presentation next week. This will occur at the US Society of Investigative Dermatology (SID) meeting, which will be held from May 15-18 in Dallas, Texas.

For the first time, JW Pharmaceutical will present the positive preclinical results of JW0061’s efficacy in human skin organoids (along with other models). Key quotes:

“Various non-clinical trials have confirmed JW0061’s excellent hair growth and follicular neo-genesis effects. JW Pharmaceutical plans to start Phase I clinical trials within the year.”

Previously, they had aimed to start clinical trials in the first half of 2024 (see bottom part of this post). In spite of the small delay, this is still positive news.

Update: August 29, 2023

JW Pharmaceutical’s JW0061 Wnt-targeted hair loss treatment just got selected as the “first national new drug development project” in 2023 in South Korea. Additionally, the company signed a research and development agreement with the Korea Drug Development Fund (KDDF). As a results, JW Pharmaceutical will receive nonclinical research funding for JW0061 for the next two years from the KDDF.

July 22, 2023

JW Pharmaceutical’s JW0061 Hair Loss Treatment

I previously mentioned JW Pharmaceutical (South Korea) in my post on activating the Wnt signaling pathway for hair growth. The latter is also referred to as the Wnt/β-Catenin pathway.

JW Pharmaceutical’s JW0061 is a first-in-class drug candidate that promotes hair regeneration by activating the Wnt pathway in skin and hair follicle stem cells. However, the company is yet to begin Phase 1 clinical trials, so I delayed writing this post. JW0061 was developed through JW Pharmaceutical’s AI-based data science platform called JWELRY. JW0061 directly binds to GFRA1 protein in dermal papilla cells and activates the Wnt signaling pathway.

Previously, by far the most well known company that was working in this area of Wnt activation and hair loss was the much hyped Samumed (US). Unfortunately, it folded in 2022 despite completing Phase 3 clinical trials.

Also of note, another South Korean company named CK Regeon (previously CK Biotech) is working on a much anticipated peptide to restore Wnt/beta-catenin signaling and hair growth. This peptide is known as PTD-DDM or KY19382. It works by inhibiting the interaction between CXXC-type zinc finger protein 5 (CXXC5) and dishevelled (Dvl). Very different from JW Pharma’s mechanism of action (see further below).

JW Pharmaceutical Wnt Activator
JW Pharmaceutical Wnt Activator (JW0061) for Hair Growth.

JW Pharmaceutical to Begin Clinical Trials in 2024

Yesterday, a reader sent me a link to an update on JW Pharmaceutical’s patent application for its JW0061 Wnt activator product. Apparently, the company has applied for patents in over ten countries. They already got a patent approved in Russia in March 2023, and have now obtained a patent in Australia.

On JW Pharma’s website, the product is listed as being in pre-clinical phase on the pipeline page. However, in this latest article, there is an encouraging quote:

“JW Pharmaceutical is currently conducting toxicity evaluation according to Good Laboratory Practice (GLP) at global institutions with the goal of starting clinical trials of JW0061 in the first half of 2024.”

This is confirmation of an estimate JW Pharmaceutical also gave last year. According to a company representative, JW0061 will complement and replace existing hair loss treatments. JW plans to develop JW0061 as a topical drug.

Note that even as far back as 2017, JW Pharma partnered with U Penn and Dr. George Cotsarelis to develop this very treatment. It was at the time called CWL080061.

Activating the Wnt Pathway by Binding to the GFRA1 Protein

In November 2022, JW gave a detailed update on their website in regards to the mechanism behind JW0061 and its hair growth effect. This was based on a presentation given at the Wnt 2022 conference in Japan. See the enlarged image here.

It demonstrated preclinical efficacy for hair regeneration in mice. According to preclinical data, JW0061 activates the Wnt signaling pathway by directly binding to the GFRA1 protein in dermal papilla cells.

Wnt/β-catenin signaling is crucial for hair growth in any area of the human body. It is the most researched area in the hair loss world. I must have written at least 50 posts on this blog in which I at least briefly mention Wnt. Even wounding induced hair growth (such as from microneedling or fractional lasers) is connected to activation of the Wnt/Beta-Catenin pathway.

Some natural products such as methyl vanillate also activate the Wnt/β-Catenin signaling pathway and promote hair growth. Dr. John Cole’s company used to sell a Wnt Act spray on Amazon, but it is always out of stock these days.

Bioengineering Approaches to Hair Regeneration: Kageyama

Recently, Yokohama National University (Japan)’s Dr. Tatsuto Kageyama published a very lengthy and detailed paper in a Japanese scientific journal called Journal of the Society of Bioengineering. Dr. Kageyama works at the renowned Fukuda Lab in Japan, which is led by Dr. Junji Fukuda. The actual paper is in Japanese and is titled: “Bioengineering approaches for hair follicle regeneration.

I have translated it and will break out the main details in this post. Besides discussing his team’s scientific approach to hair regrowth, Mr. Kageyama also outlines their overall progress and future plans (though he gives on exact dates for clinical trials). Make sure to check out the diverse range of Google Scholar citations for Mr. Kageyama. In most of his important hair growth related papers, he is a co-author with Dr. Fukuda and others.

Previously, I also mentioned that Ayaka Nanmo, Tatsuto Kageyama and Junji Fukuda are co-founders of a new company named TrichoSeeds. It aims to provide “hair regeneration medicine.”

Bioengineering Approaches for Hair Regeneration

To start off, Mr. Kageyama outlines the three main methods of hair regeneration that his team at Fukuda Lab is working on:

  1. Mesenchymal cell transplantation. Reactivates existing weakened hair follicles by injecting mesenchymal stem cells.
  2. Hair follicle primordium transplantion. See their pending patent on hair follicle primordia.
  3. Hair follicle regeneration. The creation of brand new hair follicles in those who have none left. See their January 2024 study on the large-scale preparation of hair follicle germs (HFGs). The transplantation of HFGs in mice resulted in highly efficient “de novo” hair follicle regeneration.
Bioengineering Approaches to Hair Regeneration
Bioengineering Approaches to Hair Regeneration. Journal of the Society of Bioengineering Volume 102, Issue 4 (2024). Tatsuto Kageyama.

I am most excited about the first method for now since it will come to market first. Especially in aging Japan, where autologous regenerative medicine treatments are going to be speed tracked to in-clinic use. In fact in my recent post titled “A Visit to Fukuda Lab“, Dr. Junji Fukuda had the following quote:

“Dermal papilla cell transplantation is about to begin in Japan.“

If you have a reasonable amount of your own scalp hair remaining, this mesenchymal stem cell injection treatment sounds very promising. The diagram below that Mr. Kageyma published in his new paper is extremely detailed.

Techniques for Culturing Dermal Papilla Cells

Mr. Kageyama discusses his team’s three unique approaches to culturing dermal papilla cells. I covered these methods in various posts and updates related to Dr. Junji Fukuda’s published papers over the past decade.

The conventional dermal papilla culturing method (number 1 below) is similar to Shiseido’s work, which Mr. Kageyama discusses briefly. He says that it has limited effectiveness, since the hair regeneration ability of the cells is reduced during the process of growing mesenchymal cells in a culture dish.

  1. Conventional culturing.
  2. Gel bead culture.
  3. Electrical stimulation culture.
  4. Startified culture.
Mesenchymal Stem Cell Culturing Hair Growth
Mesenchymal stem cell culturing and injection of derma papilla cells for hair growth. Journal of the Society of Bioengineering Volume 102, Issue 4 (2024). Tatsuto Kageyama.

Hair Regeneration by Transplantation of Hair Follicle Primordia

In this second key approach, the aim is to increase the total number of existing hairs. Dr. Kageyama also discusses the work of Dr. Takashi Tsuji and his team in this section of the paper.

The gist of this technology is the mixing of epithelial cells and mesenchymal cells into a single aggregate. This in turn results in the formation of hair follicle primordia (hair seeds), which can then be transplanted into thinning areas of the scalp. The Fukuda team has already succeeeded in the large-scale preparation of hair follicle
primordia.

At present, the team is conducting experiments in transplanting human hair follicle primordia into mice and improving the regeneration efficiency. At present, there is no guarantee that hair follicle will regenerate from the transplanted seeds. It is also difficult to control the direction of new hair growth with this approach.

Hair Follicle Regeneration

The third and final approach entails the creation of brand new hair follicles for transplantation. i.e., hair multiplication. The Fukuda Lab team has managed to develop a culturing technique for regenerating hair follicles in vitro. The discussion here is fairly technical, so I will just quote (and hope that the translation is accurate):

“Focusing on the self-organization process of epithelial cells and mesenchymal cells, we regenerate mature hair follicles with high efficiency (>99%) by controlling the spatial arrangement pattern of aggregates that form in the early stage of culture. Controlling the spatial arrangement of epithelial cells and mesenchymal cells in the aggregate on the second day of culture from a dumbbell shape to a core-shell shape was the key to in vitro hair regeneration. The production method is very simple, such as adding approximately 2% Matrigel to the culture medium when seeding epithelial cells and mesenchymal cells.”

Hair Follicle Regeneration In Vitro
Hair Follicle Regeneration In Vitro. Journal of the Society of Bioengineering Volume 102, Issue 4 (2024). Tatsuto Kageyama.

Future Plans

The team plans to continue its work in all three approaches to hair regeneration. i.e., transplantation of mesenchymal cells,
transplantation of hair follicle primordia, and transplantation of regenerated hair follicles. Moreover, they have succeeded in constructing microtweezers that can grasp, cryopreserve, and eject hair follicle primordia. They are also working with robotics experts to develop a fully automated transplantation robot.

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