- -First Efficacy Evaluation on Human Skin Organoids and Androgenic Alopecia Animal Model Revealed at the Society of Investigative Dermatology
- -Demonstrated Excellent Hair Follicle Proliferation and Hair Growth Compared to Standard Treatments
- -Innovative First-in-Class Drug Activating Wnt, First to Elucidate Hair Growth Mechanism
- -Developed as a Global New Drug that Can Complement and Replace Existing Hair Loss Treatments, Suitable for Both Men and Women'
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May 2024
JW Pharmaceutical announced on the 20th that it had presented the superiority of Wnt-targeted hair loss treatment ‘JW0061’ in hair follicle formation and hair growth compared to existing treatments at the Society of Investigative Dermatology, held from May 15 to 18 in Dallas, Texas.
At this conference, JW Pharmaceutical revealed for the first time the efficacy of JW0061 evaluated on human skin organoids (organ-like structures) and an androgenic alopecia animal model.
The study using skin organoids differentiated from human induced pluripotent stem cells was designed to predict whether JW0061 generates hair follicles on the actual human scalp. Organoids can replace animal testing and are a next-generation drug development technology that can assess drug efficacy without direct human trials.
When JW0061 and the standard treatment were applied to skin organoids, the number of hair follicles in the JW0061-treated organoids significantly increased compared to the standard treatment. Specifically, JW0061-treated organoids had 7.2 times and 4.0 times more hair follicles on the 5th and 10th days of drug application, respectively, than the standard treatment.
Notably, JW Pharmaceutical’s skin organoid research presentation was the only result in the poster session at this conference, drawing significant attention from participants.
In addition, the hair growth effect was confirmed in an androgenic alopecia animal model induced by the male hormone testosterone.
The androgenic alopecia animal model was divided into four groups: low-dose JW0061, high-dose JW0061, standard treatment (SoC), and placebo. Both low-dose and high-dose JW0061 groups showed faster hair growth promotion compared to the standard treatment. On the 17th day of administration, low-dose and high-dose JW0061 showed 18% and 39% efficacy improvement, respectively, compared to the standard treatment, demonstrating dose-dependent responses.
The efficacy presented at this conference resulted from JW0061 directly binding to the GFRA1 protein in dermal papilla cells and activating the Wnt signaling pathway. JW Pharmaceutical previously gained attention by presenting JW0061 as the first low-molecular-weight drug to elucidate the hair growth mechanism at the ‘Wnt 2022’ conference.
JW0061 is an innovative first-in-class drug 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, located at the base of hair follicles, regulating hair growth and maintenance.
Based on the various preclinical results, including those presented at this conference, and the toxicity evaluations completed according to GLP (Good Laboratory Practice) at overseas institutions, JW Pharmaceutical plans to initiate Phase 1 clinical trials within this year.
A representative from JW Pharmaceutical stated, “We expect JW0061 to emerge as a promising treatment option that can complement or replace existing hair loss treatments in the global market through this conference presentation. We will develop JW0061 into a global innovative hair loss treatment that is safe and effective for both male and female hair loss patients.”
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.