Zylö Receives $294,000 NIH Phase I Grant to Advance its Cutaneous Lupus Program

Funds to be used to demonstrate efficacy in a new mouse model of cutaneous lupus

GREENVILLE, SC, May 31, 2023 (GLOBE NEWSWIRE) -- Zylö Therapeutics Inc., developer of the Z-pod® topical delivery platform, has been awarded a two-year $294,000 Small Business Technology Transfer Research (STTR) grant to: (i) demonstrate that a formulation of N-acylethanolamine (AEA or anandamide) loaded into Zylö’s novel Z-pod delivery system is efficacious (and well tolerated) in a new mouse model of cutaneous lupus developed at Yale University, and (ii) conduct preliminary stability studies to prepare for an eventual investigational new drug (IND) application to the FDA. The grant is sponsored by the NIH’s National Institute of Arthritis and Musculoskeletal/Skin Disease under Award 1R41AR082749.

The principal investigator of the project is Andrew Draganski, Ph.D., Zylö’s head of product development. The primary collaborator is Victoria Werth M.D., a professor of dermatology at the Perelman School of Medicine at the University of Pennsylvania and the chief of dermatology at the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center in Philadelphia. Dr. Werth is one of the world’s foremost authorities on cutaneous lupus.

Approximately 500,000 people in the U.S. suffer from cutaneous lupus erythematosus (CLE), with a significant impact on quality of life. Unfortunately, there is no cure, the treatment options are limited, and no new drug has been FDA-approved for over 50 years. There is compelling preliminary data to support AEA-loaded Z-pods as a promising drug candidate for CLE, including two in vivo mouse studies that demonstrated statistically significant reduction in the size and severity of lupus lesions as compared to controls, including AEA without the Z-pods.

“We once again thank the NIH for their support as we leverage our patent-pending technology to advance innovative treatments for a wide variety of diseases and conditions,” said Andrew Draganski, Ph.D.

Dr. Werth added, “We’re looking forward to see if this platform technology provides an improved treatment for patients that suffer from CLE. Only one drug is approved for treatment, but only for a single subtype of CLE. First-line therapy often involves corticosteroids, which must be used with caution and for limited duration. Systemic immunomodulatory medications can be used in more severe cases, but these carry risks of serious side effects. Quality of life for those with CLE would be greatly improved with a new drug.

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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Scott R. Pancoast
CEO + Founder