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22.11.21 Hair Loss Treatment by JW0061-mediated Wnt modulation for “Growth in Hair length & follicular number”

-Wnt pathway activation via GFRA1 receptor binding is a key action mechanism of hair regeneration…First reported case of synthetic small molecule
-The excellent efficacy to growth in hair shaft and hair follicles was confirmed…Verification of equivalent or higher effects compared to the standard of care drug


2022. 11


JW Pharmaceutical announced on the 21st that JW researchers unveiled action mechanism of the newly identified Wnt-modulating small molecule, "JW0061" and demonstrated preclinical efficacy for hair regeneration at the "Wnt 2022" conference.


The WNT signaling is playing a critical role in the differentiation of skin stem cells into hair follicles. In particular, Dermal Papilla (DP) cells as a dermal organizing center are well known for providing inductive signals to promote growth and differentiation of surrounding cells during hair growth, which mainly relies on an intracellular WNT signaling.


JW0061 is a first-in-class drug candidate that promotes hair regeneration by activating the Wnt pathway in skin and hair follicle stem cells.


According to the preclinical data, JW0061 activates the Wnt signaling pathway by directly binding to the GFRA1 protein in the dermal papilla cells.


JW researchers further demonstrated that JW0061 induces anagen phase in hair growth cycle and hair regeneration that are highly correlated with WNT activation in various efficacy models. In detail, the hair growth cycle is made up of three phases: anagen, catagen and telogen. The anagen is also referred to as the active phase of hair growth whose defects mostly cause hair loss. JW0061 was shown to make the entry of anagen earlier by more than 15 days, which takes 50 days on average in mice, and be efficacious to growth in hair shaft and new hair follicles in 34 days after application, which are comparable to or higher than that of the standard of care (SoC) drug. Moreover, the combination therapy of JW0061 with the SoC drug synergized the maximum hair growth effect.


 JW Pharmaceutical plans to develop JW0061 as a new topical drug supplementing and replacing existing hair loss treatments in the future. Currently, GLP toxicological evaluation is being conducted, aiming at a clinical trial of JW0061 in the first half of 2024, and collaboration research is also underway with a key opinion leader in dermatology field in the USA.


Chan-hee Park, chief technology officer (CTO) of JW Group, said, “Among standard treatments on the market and various clinical trials for androgenic alopecia, there is no drug that clearly identifies the action mechanism of hair growth and its binding target protein.” He also said, “The JW0061 data will draw attention as an innovative drug candidate targeting GFRA1 for hair loss treatments.”


Meanwhile, the Wnt international conference has an important objective to bring together various researchers for exchanging cutting-edge information, leading to advance of the Wnt research area. The year of “2022” marks the 40th anniversary of the discovery of the Wnt protein, and the in-person conference was held in Awaji, Japan for the first time in three years after last meeting. Researchers gathered from academia, pharmaceutical and bio companies in Asia, Oceania, the US as well as Europe.

◎ Wnt Signaling Pathway
Various studies have shown over the past 40 years that the Wnt signaling pathway exists across all species, from nematodes to mammals, and plays an essential role in cell proliferation and differentiation, organ generation, and morphogenesis. Impeding the Wnt pathway inhibits the formation, proliferation, and metastasis of cancer cells in various tissues. Conversely, the Wnt pathway activation is involved in tissue regeneration through stem cell promotion and cell proliferation. Likewise, the Wnt pathway affects many human diseases, but so far, no new drug is available to control this pathway.


◎JW Pharmaceutical Wnt Targeted First-In-Class R&D
JW Pharmaceutical has been focusing on development of new drugs controlling Wnt signaling pathway since the early 2000s. "JWELRY," a data science platform specialized in the Wnt signaling pathway, is being used as a core technology where we screen drug candidates from tens of thousands of compound libraries and conduct mechanism studies associated with Wnt signaling pathway. Currently, various new drug candidates were nominated in the fields of anticancer, regenerative medicine, and immune diseases. In addition, joint research is being conducted by harmonizing domestic and foreign Biotech's AI (Artificial Intelligence) platforms in order to explore new indications of own drug candidates in JW pharmaceutical.


◎ Hair Loss and Treatment Market
Hair loss is caused by various causes such as genetic factors, autoimmune diseases, and mental stress, and the number of patients is rapidly increasing. Currently, primary hair loss treatments include Finasteride, Dutasteride, and Minoxidil. Finasteride and Dutasteride are prescribed to male patients, and there is a possibility of on-target side effects. Minoxidil can be prescribed to both male and female patients, and its disadvantages are that the mechanism is unclear and hair loss recurs soon after stopping medication. Altogether, there is a great demand for hair loss treatments which have a clear mechanism of hair growth and can be safely used by both genders. The global market is worth 8 trillion won as of 2020, and the related market is growing by 8% every year. According to Global View Research, a global market research company, it is expected to be worth of 15 trillion won by 2028.