- -Discovered through the new drug development platform ‘JWELRY,’ targeting the Wnt signaling pathway for hair loss treatment
- -First efficacy evaluation on human skin organoid model revealed at international dermatology research conference
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May 2024
JW Pharmaceutical announced on the 7th that it will present the preclinical results of its Wnt-targeted hair loss treatment ‘JW0061’ through a poster presentation at the Society of Investigative Dermatology conference, which will be held from May 15 to 18 in Dallas, Texas.
JW0061 is an innovative new drug (First-in-Class) candidate that promotes hair follicle proliferation and hair regeneration by activating the Wnt signaling pathway. This substance was discovered through JW Pharmaceutical’s AI-based data science platform, ‘JWELRY.’
The Wnt signaling pathway plays a crucial role in skin development and hair follicle formation during embryogenesis and body growth, promoting hair follicle differentiation of skin stem cells. It is particularly involved in the proliferation of dermal papilla cells, which are located at the base of hair follicles and regulate hair growth and maintenance.
JW0061 directly binds to the GFRA1 protein in dermal papilla cells, activating the Wnt signaling pathway. JW Pharmaceutical previously garnered attention by presenting JW0061 as the first low-molecular-weight drug to elucidate the hair growth mechanism at the ‘Wnt 2022’ conference.
At this year’s Society of Investigative Dermatology conference, JW Pharmaceutical will reveal efficacy evaluation results on various models, including human skin organoids.
Organoids are next-generation drug development technologies that can replicate the structural and functional characteristics of patient organ tissues. They can replace animal testing and predict clinical trial results without directly conducting human trials.
Based on preclinical research results, JW Pharmaceutical plans to initiate Phase 1 clinical trials within this year. The company has already completed toxicity evaluations according to GLP (Good Laboratory Practice) at overseas institutions and is producing clinical-grade drugs.
A JW Pharmaceutical representative stated, “Various preclinical tests have confirmed JW0061’s excellent hair growth and hair follicle regeneration effects. Through this conference presentation, we aim to establish the potential of JW0061 as an innovative treatment option that can complement and replace existing hair loss treatments internationally.”
Meanwhile, JW0061 was selected as a project supported by the National New Drug Development Institute last year and received funding for preclinical research.
About Hair Loss Disorders and Treatment Market
Hair loss can be caused by various factors, including genetic predisposition, autoimmune diseases, and mental stress, leading to a rapid increase in patient numbers. Currently, the main first-line treatments for hair loss are finasteride, dutasteride, and minoxidil. Finasteride and dutasteride are prescribed for male patients and can cause mechanism-specific side effects. Minoxidil is primarily prescribed for female patients, but its hair growth mechanism is unclear, and hair loss recurs soon after discontinuation. Therefore, there is a significant unmet need for a hair loss treatment with a clear mechanism of action that is safe for both men and women.
According to the National Institutes of Health, hair loss affects 42% of men worldwide, with approximately 80 million people (25% of the total population) affected in the United States. The Korean Hair Society estimates the domestic hair loss population to be around 10 million (20% of the total population).
Market research agencies estimate the global hair loss treatment market to be valued at 10 trillion KRW as of 2021, growing at an annual rate of 8.2%. The market is projected to reach nearly 16 trillion KRW by 2028 (Research and Markets, 2021).
About the Wnt Signaling Pathway
The Wnt signaling pathway is present across all species, from nematodes and fruit flies to mammals, and plays a crucial role in cell proliferation, differentiation, organ development, and morphogenesis, as revealed by various studies over the past 40 years. Inhibiting the Wnt pathway suppresses the formation, proliferation, and metastasis of cancer cells within various tissues. Conversely, activating the Wnt pathway promotes tissue regeneration by stimulating stem cells and inducing cell proliferation. Despite its influence on many human diseases, there are currently no drugs targeting the Wnt pathway.
About the Development of Innovative New Drugs Targeting Wnt and STAT Based on Data Science Platforms
Since the 2010s, JW Pharmaceutical has been building AI and deep learning-based data science platforms ‘JWELRY’ and ‘CLOVER,’ in addition to chemical and bioinformatics big data. Through these platforms, JW Pharmaceutical continues to generate new drug candidates targeting Wnt and STAT for cancer, regenerative medicine, and immune diseases.
Since the early 2000s, JW Pharmaceutical has focused on developing new drugs targeting the Wnt signaling pathway. Currently, the company utilizes 'JWELRY' (JW Excellent LibraRY), a core proprietary technology specializing in the Wnt signaling pathway. JWELRY is based on a library of tens of thousands of compounds involved in the Wnt pathway, along with drug evaluation and mechanism research technologies for distinguishing inhibition and activation of the Wnt pathway. Through JWELRY, JW Pharmaceutical has identified various new drug candidates, including JW0061, and is generating new projects.
In addition, JW Pharmaceutical is actively developing new drugs targeting the STAT protein through ‘CLOVER’ (C&C research Laboratories Omics serVER), established by the research subsidiary C&C New Drug Research Institute. The company focuses on discovering innovative new drug candidates targeting each subtype of the STAT protein, such as the STAT3-targeted anticancer drug JW2286, a STAT3 atopic dermatitis treatment, a STAT5-targeted anticancer drug (for hematologic cancers), and a STAT3-ADC anticancer drug (for solid tumors).
Furthermore, JW Pharmaceutical is conducting joint research incorporating AI and organoid platforms from domestic and international biotech companies to explore new indications for its drug candidates and validate their development potential.