JW Pharmaceutical announced on the 28th that its Wnt-targeting alopecia treatment ‘JW0061’ has been selected as a supported project for the ‘2023 1st National New Drug Development Project’ and has signed a research and development (R&D) agreement with the National New Drug Development Project Group.
The National New Drug Development Project is a government-led, cross-ministerial R&D initiative that supports the entire new drug development cycle to strengthen the global competitiveness of the domestic pharmaceutical and bio industry and promote public health. Through this agreement, JW Pharmaceutical will receive funding for preclinical research of JW0061 from the National New Drug Development Project Group for the next two years.
JW0061 is a first-in-class innovative drug candidate that activates the Wnt signaling pathway in the skin and hair follicle stem cells, promoting hair follicle proliferation and hair regeneration. The Wnt signaling pathway plays a crucial role in skin development and hair follicle formation during embryogenesis and is necessary for skin stem cells to differentiate into hair follicle stem cells. In particular, it is involved in the proliferation of dermal papilla cells located at the root of the hair, which regulate hair growth and maintenance.
JW Pharmaceutical participated in the ‘Wnt 2022’ conference held in Japan last November, where it first disclosed the preclinical results of JW0061. It newly confirmed the mechanism of action in which JW0061 directly binds to the GFRA1 protein in dermal papilla cells, activating the Wnt signaling pathway. This was noted as the first reported case of a small molecule drug elucidating the mechanism of hair growth. Additionally, animal experiment results were presented showing JW0061’s superior hair growth and hair follicle neogenesis effects compared to the placebo group. Hair growth cycles through three stages?anagen, catagen, and telogen?with the anagen phase lasting on average more than 50 days. Application of JW0061 advanced the entry into the anagen phase by more than 30% (15 days).
JW Pharmaceutical aims to start clinical trials of JW0061 in 2024. Currently, toxicity evaluations according to GLP (Good Laboratory Practice) standards are being conducted at global institutions. Alongside this, production of clinical-grade drug substances and optimization studies for transdermal formulations are underway.
A JW Pharmaceutical official stated, “JW0061 specifically activates GFRA1, a novel target unrelated to male hormones, making it suitable for both male and female alopecia patients, and we expect it to have excellent safety. With the selection of this national project, we will promptly complete the preclinical trials of JW0061 and develop it as a global innovative drug that complements and replaces existing alopecia treatments.”
The global alopecia treatment market was valued at 10 trillion KRW in 2021 and is expected to grow annually by 8.2%, reaching 16 trillion KRW by 2028.
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