Zylö Receives $600,000 NIH Phase I Grant to Develop a Novel Therapeutic to Treat Onychomycosis

Zylö Receives $600,000 NIH Phase I Grant to Develop a Novel Therapeutic to Treat Onychomycosis

Zylö Therapeutics Inc., developer of the Z-pod® topical delivery platform, has been awarded a two-year $600,000 Small Business Innovation Research (SBIR) grant to generate a final formulation of Zylö’s proprietary nitric oxide-releasing topical drug candidate optimized for the treatment of onychomycosis. The grant is sponsored by the National Institute of Allergy and Infectious Diseases, a division of the NIH.

The principal investigator of the project is Andrew Draganski, Ph.D., Zylö’s head of product development and adjunct professor at Clemson University; the primary collaborator is Joshua Nosanchuk, M.D., professor in the department of medicine and the department of microbiology and immunology and senior associate dean for medical education at Albert Einstein College of Medicine.

Onychomycosis is an extremely common and difficult-to-treat fungal nail infection that causes nail disfigurement, pain, associated infections, and psychosocial effects that negatively impact quality of life. The condition is typically treated by antifungal drugs administered systemically or topically, but each approach has significant shortcomings leading to low complete cure rates.

Systemic antifungals are generally high cost and are associated with potentially severe adverse effects including liver toxicity; they also increase the risk of development of drug-resistant pathogens. While the topical approach is much preferred, current topical antifungals are limited by difficulties in getting the drug through the nail plate—a highly keratinized, protective barrier—and to the nailbed, where the fungus resides.

The nitric oxide gas that is released by Zylö’s Z-pod drug candidate has an extremely low molecular weight, thereby allowing efficient penetration of nitric oxide through the nail plate. Further, treatment with nitric oxide is less likely to lead to the development of drug resistance. Combined, these factors suggest that the Zylö product concept can exceed the efficacy levels of current topical treatments and also avoid the toxicity and resistance-related risks associated with systemic drugs.

Andrew Draganski Ph.D. commented, “Zylö’s nitric oxide technology is a potential breakthrough in the treatment of nail fungus. Our novel nitric oxide-releasing product promises to increase nail penetration, thereby enhancing efficacy, but without the side effects typically experienced with systemic drugs. If successful, this program would fill a significant unmet clinical need, reduce the overall healthcare expense burden, and improve the quality of life for those affected by the disease.”

Added Jay Blankenship MD, Zylö’s senior vice president of development, “We are enthused by the opportunity afforded by the NIH to advance our innovative approach to delivering nitric oxide through topical administration. This patent-pending technology holds great promise not just for onychomycosis, but for a myriad of other clinical applications such as erectile dysfunction, wound healing, acne, and atopic dermatitis, among others.”

About Zylö Therapeutics
Zylö has developed the Z-pod® technology platform, a disruptive topical delivery system that extends duration of effect, improves targeting, and enhances product performance of many therapeutic and cosmetic agents. Notably, the Z-pod® technology can also be adapted to provide sustained topical delivery of nitric oxide for multiple therapeutic indications. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).

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