Zylö Receives $263,000 NIH Phase I Grant to Develop a Topical Viagra® for ED

Funds to be used to optimize a formulation and demonstrate comparable efficacy to oral Viagra

GREENVILLE, SC, Sept. 16, 2022 (GLOBE NEWSWIRE) -- Zylö Therapeutics Inc., developer of the Z-pod^® topical delivery platform, has been awarded a one-year $263,000 Small Business Innovation Research (SBIR) grant to: (i) optimize a formulation of sildenafil (generic name of Viagra) loaded into Zylö’s proprietary silica-based Z-pods and (ii) demonstrate that the topical formulation is comparable in efficacy to orally administered sildenafil in a mouse model of erectile dysfunction [ED], with aged mice. The grant is sponsored by the National Institute of Diabetes and Digestive and Kidney 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 Kelvin Davies Ph.D., professor in the departments of urology and molecular pharmacology at Albert Einstein College of Medicine.

ED is a medically significant issue: Not only does it affect a man’s sex life, it also impacts his relationships and overall psychological well-being. An indication of the importance of erectile function to men is that in the first six years after FDA approval of Viagra, 23 million men worldwide filled Viagra prescriptions, with peak annual sales for Pfizer of $2.1 billion, making it one of the more commercially successful drugs of all time.

Unfortunately, there are multiple side effects associated with the use of Viagra and the other drugs in its class (such as Cialis^® and Levitra^®), including headaches, facial flushing, and indigestion/heartburn. In addition, certain medications and foods can alter the absorption of these drugs, potentially leading to problematic outcomes; and men that have cardiovascular disease or that suffer from certain blood-pressure issues must use these drugs with caution. Finally, a major complaint by men using these drugs is the long lag period prior to effect, which is thought to be related to the time to reach the target tissue following oral administration.

Combined, these factors cause a 70% prescription-discontinuance rate for men that initiate a treatment regimen with these drugs.

A local topical application for sildenafil could, therefore, hold several advantages over oral administration, including: (i) reduced side effects associated with systemic delivery; (ii) decreased variation in absorption profiles due to diet and other medications; and (iii) improved time of onset because of shorter distance to the target organ.

Andrew Draganski Ph.D. commented, “Zylö’s platform technology holds the promise of providing a solution for men with ED that do not respond well to Viagra and the other drugs in this PDE5-inhibitor class. There are currently no other approved treatments for men that suffer from ED, so the quality-of-life impact can be significant.”

Added Jay Blankenship MD, Zylö’s senior vice president of development, “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.”

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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