KLS-13022 topical therapy for radiation dermatitis and skin disorders
KLS-13022 is a novel synthetic compound formulated as a topical cream for treating and preventing dermatological disorders including atopic dermatitis, UV-B-induced inflammation, and radiation dermatitis. Preclinical and human diary studies demonstrate significant reductions in key symptoms such as dryness, itching, and skin irritation. The product is OTC-ready and cleared for personal care use.
Overview
KLS-13022 is a proprietary synthetic compound developed by Kannalife Sciences, Inc. for the topical treatment of dermatological disorders. Designed to address conditions such as atopic dermatitis, persistent inflammation from UV-B exposure, and radiation dermatitis, the compound works by reducing oxidative stress and inflammation in skin cells. Formulated as a topical cream, KLS-13022 has already been tested in human subjects and is positioned for over-the-counter (OTC) commercial distribution. The compound has been cleared by the Personal Care Product Council under classified chemical nomenclature, supporting its readiness for market entry.
Technical specifications
Mechanism of action:
- Reduces oxidative stress and inflammatory signaling in skin tissue
- Targets keratinocyte dysfunction associated with multiple dermatological conditions
Key preclinical findings:
- Decreased release of TNF-α, IL-1β, and CXCL5 in human epidermal keratinocytes exposed to UV-B radiation
- Decreased release of IL-6 in human dermal fibroblast cells undergoing UV-A-induced photoaging
- Decreased release of IL-8 in human dermal microvascular endothelial cells exposed to nickel-induced allergic response
- Maintained cell viability of human epidermal keratinocytes after treatment
Human diary study results:
- Case 1: Eleven-year-old female with mild to moderate atopic dermatitis showed a statistical score reduction from 20 to 8 over a ten-day trial
- Case 2: Sixty-two-year-old male with mild to moderate atopic dermatitis showed a statistical score reduction from 32 to 11.5 over a twenty-one-day trial
- Improvements observed across multiple metrics including dry skin, daytime itching, nighttime itching, skin clarity, bumps, fluids, calloused skin, and scratching
Technology readiness level
KLS-13022 has progressed through preclinical validation and limited human diary testing, with results indicating significant symptom reduction in atopic dermatitis cases. The topical formulation has been developed and the compound has received regulatory clearance from the Personal Care Product Council. Next steps include scaling the formulation for mass product distribution and conducting larger non-monograph human clinical trials to support a full commercial OTC launch.
About Kannalife Sciences, Inc.
Kannalife Sciences, Inc. is a biopharmaceutical company based in Doylestown, Pennsylvania, that specializes in the research and development of synthetic, cannabidiol-inspired therapeutics. A subsidiary of Neuropathix, Inc., the company focuses on creating small molecule drug candidates designed to address neuroinflammation, neuropathic pain, and neurodegenerative diseases. By utilizing proprietary technology to synthesize novel compounds, such as its lead candidate KLS-13019, Kannalife aims to optimize bioavailability and therapeutic potency to treat conditions including Parkinson’s disease, hepatic encephalopathy, and chemotherapy-induced peripheral neuropathy.
These therapeutic efforts aim to provide patients with alternatives to traditional treatments, including non-opioid options for pain management and solutions for complex neurological disorders. The company’s work is supported by strategic grants from organizations such as the National Institutes of Health and The Michael J. Fox Foundation, alongside partnerships with research institutions and pharmaceutical service providers. Through its commitment to rigorous pre-clinical development and a portfolio of patented molecular entities, Kannalife seeks to improve cellular health and address significant unmet medical needs in neurological health.
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