Hair Loss Cure 2020 | Hair loss blog with the latest news updates.

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 (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.

Update: May 6, 2024

Pelage Pharmaceuticals Phase 2 Clinical Trials Start in June 2024

Yesterday, a reader e-mailed a new link on Pelage Pharmaceuticals’ Phase 2 clinical trials for its PP405 inhibitor of mitochondrial pyruvate carrier (MPC). The Phase 2 trials are set to begin in June 2024 and will involve 60 participants. Half of these will take a PP405 0.05% topical gel once per day, and the other half will get a placebo vehicle daily gel. The study primary completion date is December 2024, and actual completion date is February 2025.

Recruitment will likely start soon, and I assume it will be in the US based on the listed contact person and phone number. The contact e-mail is listed as clinicaltrials@pelagepharma.com. Please DO NOT call them now as the recruitment has not yet commenced and they might get annoyed.

If you are between the ages of 18-55 and have androgenetic alopecia, you can participate. However, the inclusion criteria for men and women is specific:

Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.
Females must have a Savin classification score of I-2, I-3 or I-4.

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.

Update: March 9, 2024

Earlier today, Pelage Pharmaceuticals gave a positive update on its novel small molecule PP405. Full summary can be read here. In Phase 1 clinical trials, PP405 reactivated dormant hair follicle stem cells and triggered hair growth. The company’s presentation was made by Dr. Christina Weng and titled: “Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo”. Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024. It will recruit both men and women with androgenetic alopecia.

Their description of this unique hair growth molecule is as follows:

“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”

Stem cells are particularly sensitive to LDH, so this results in their activation and subsequent hair growth. PP405 demonstrates a statistically significant increase in Ki67 signaling in the hair follicle bulge. Ki67 is a well-established marker of stem cell proliferation.

February 27, 2024

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

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.

Recently, 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? I think it sounds like that latter. The company’s 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. The main 2017 study on RCGD423, lactate dehydrogenase activity and hair follicle stem cell activation can be read here. I also covered it in my earlier linked posts related to the work of Pelage co-founders Dr. William Lowry and Dr. Heather Christofk.

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. There is a 2015 study from China related to the application of mitochondrial pyruvate carrier blocker UK5099 and its effects on prostate cancer cells.