EPI-SK14/17: Seborrheic Keratosis (SK)
First SK therapy that treats tumour formation and growth
EpiPharm’s SK products are the first SK therapies that treat the cause of lesion formation, the underlying tumour formation and growth.
All compounds tested induced significant regression of SK lesions.
EPI-SK 14, a phase I/II study with Artemether has successfully been completed. The data demonstrate a clinically relevant and statistically significant regression of SK lesions in size, colour and texture. Regression continued markedly after treatment stop. The study results have been published online in the British Journal of Dermatology.
EPI-SK17 has been selected as lead product candidate based on properties which distinguish it from other artemisinin derivatives tested, including greater potency, and shorter duration of treatment. The product is about to enter phase IIb clinical development.
Seborrheic Keratosis treated with Epi-SK17
Lesion clearance after treatment
Seborrheic Keratosis (SK)
SK lesions are among the most common non-cancerous skin tumours affecting over 70% of the elderly and up to 17% of adults under 40 years of age. . It is estimated that over 83 million people in the U.S. have seborrheic keratosis . SK is one of the most frequent diagnoses made by dermatologists . SK lesions usually are treated by cryosurgery, electrodesiccation, curettage or excision. These invasive methods may be painful and or can result in pigmentary changes or scarring at the treatment site.
No available therapies or drug under approval treat the cause of SK formation, the underlying tumour genesis and growth.
1. Hafner C, Vogt T: Seborrheic Keratosis, JDDG, 2008; 8:664-677 (Vol 6)
2. Bickers DR, et al: The burden of skin diseases 2004, J Am Acad Dermatol, 2006;55:490-500
3. CDC National Ambulatory Medical Care Survey Fact Sheet. Dermatology 2009 (https://www.cdc.gov/nchs/data/ahcd/namcs_factsheet_derm_2009.pdf)
Web links to more detailed info about SK
• Balin AK. Seborrheic Keratosis. Medscape. June 28, 2016; http://emedicine.medscape.com/article/1059477.
• Oakley A. Seborrheic Keratosis. DermNet NZ. January 2016; http://www.dermnetnz.org/topics/seborrhoeic-keratoses/.
• Seborrheic keratoses. American Academy of Dermatology. https://www.aad.org/public/diseases/bumps-and-growths/seborrheic-keratoses#overview.
EPI-N06: Hyperpigmented Melanocytic Lesions
Effective and lasting treatment of hyperpigmented spots
Age spot treatead with Epi-N06
Dermoscopic image – Significant regression in size and colour
EPI-N06 is a topical, novel and effective treatment of melanocytic pigmented lesions which targets the melanin formation by synergistic mechanisms of action and by different pathways.
A phase I/II study has successfully been completed in melanocytic pigmented lesions (nevi and age spots) without tolerability issues. Data demonstrated clinically relevant regression of lesions size and colour and a marked reduction of melanin in the epidermis.
Confocal microscopy image – Relevant decrease of fluorescent melanin
Melanogenesis is a complex process and involves different signaling pathways (uv radiation, immune, inflammation, endocrine) and different stages of melanin synthesis . Currently available treatments are used with variable results and rather low efficacy.
Sun/Age Spots affect about 400 to 600 Mio persons in EU and North America and is triggered by prolonged sun exposure, > 60% of Caucasians have sun/age spots .
Melasma occurs predominantly in persons with Fitzpatrick skin types IV to VI and is triggered by sun exposure, pregnancy or oral contraceptives. It has a high prevalence especially in latino females (8%-36%) and the Asian population (up to 40%) .
1. Dos Santos V et al: Mechanisms Regulating Melanogenesis, An Bras
Dermatol 2013, 88 (1):76-83
2. Mello et al: Signaling Pathways in Melanogenis, Int J Mol Sci 2016,
3. Schaefer T, et al: The Epidemiology of Nevi and Signs of Skin Aging,
J Invest Dermatol 2006, 126:1490-1496
4. Sheth VM, Pandya AG: Melasma: A Comprehensive Update. Part I, J Am
Acad Dermatol 201, 65(4): 6989- 6996