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

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

GREENVILLE, South Carolina, Sept. 16, 2022 (GLOBE NEWSWIRE) — Zylö Therapeutics Inc., developer of the Z-pod® topical delivery platform, was awarded a one-year, $263,000 Small Business Innovation Research (SBIR) grant to: (i) optimize a formulation of sildenafil (generic name of Viagra) loaded in Zylö’s proprietary silica-based Z-pods and (ii) demonstrate that the topical formulation has comparable 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 project’s principal investigator is Andrew Draganski, Ph.D., product development manager at Zylö and assistant professor at Clemson University; the main collaborator is Kelvin Davies Ph.D., a professor in the departments of urology and molecular pharmacology at the Albert Einstein College of Medicine.

Erectile dysfunction is a significant medical issue: not only does it affect a man’s sex life, but it also impacts his relationships and overall psychological well-being. An indication of the importance of erectile function for men is that in the first six years after Viagra was approved by the FDA, 23 million men worldwide filled Viagra prescriptions, with sales maximum annual revenues for Pfizer of $2.1 billion, making it one of the most successful drugs commercially. all time.

Unfortunately, there are multiple side effects associated with the use of Viagra and other drugs in its class (such as Cialis® and Levitra®), including headaches, flushing and indigestion/heartburn. Additionally, certain medications and foods can alter the absorption of these medications, which can lead to problematic results; and men who have cardiovascular disease or suffer from certain blood pressure problems should use these medications with caution. Finally, a major complaint from men using these drugs is the long lag period before effect, which is thought to be related to the time it takes to reach the target tissue after oral administration.

Together, these factors lead to a 70% discontinuation rate among men who initiate a treatment regimen with these drugs.

Local topical application of sildenafil could therefore have several advantages over oral administration, including: (i) a reduction in side effects associated with systemic administration; (ii) decreased variation in absorption profiles due to diet and other drugs; and (iii) improved onset time due to shorter distance to the target organ.

Andrew Draganski Ph.D. commented, “Zylö’s technology platform promises to provide a solution for men with erectile dysfunction who do not respond well to Viagra and other drugs in this class of PDE5 inhibitors. There are currently no other approved treatments for men with erectile dysfunction, so the impact on quality of life can be significant.

Jay Blankenship MD, Senior Vice President of Development at Zylö, added, “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 illnesses and ailments.

About Zylö Therapeutics: Zylö developed the Z-pod® technology platform, a disruptive topical delivery system that prolongs duration of effect, improves targeting and enhances product performance of numerous therapeutic and cosmetic agents. In particular, the Z-pod® The 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.comand follow us on Twitter (@ZyloTherapies).

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