Zylö’s Erectile Dysfunction Product Concept Wins Best Abstract Award

The product concept uses patent-pending Z-pods^™ to sustainably—for over an hour—release nitric oxide

GREENVILLE, SC, Nov. 10, 2021 (GLOBE NEWSWIRE) -- A novel nitric-oxide-releasing product concept developed by Zylö Therapeutics was awarded Best Abstract - Basic Science at the annual scientific meeting of the North American Sexual Medicine Society of North America (SMSNA), held October 21-24 in Scottsdale. The abstract, titled “Synergy Between Sildenafil and Topically Delivered Nitric-Oxide in Eliciting an Erectile Response in a Rat Model of Radical Prostatectomy” was presented by Moses Tar M.D. of Albert Einstein College of Medicine and was co-authored by Andrew Draganski Ph.D., Zylö’s director of product development, and Kelvin Davies Ph.D., professor of urology and professor of physiology and biophysics at Einstein College.

This work, funded by a $225,000 NIH STTR grant award, demonstrated compelling results in a radical prostatectomy rat model of ED. In this model, the cavernous nerve of the rat is surgically severed such that the rat is sexually dysfunctional and does not respond to sildenafil (a.k.a. Viagra^®) and other PDE5 inhibitors. Following a single topical application of the nitric-oxide-releasing Z-pod^™ formulation, the rats experienced 2.0 erections on average during the 60-minute observation period immediately following administration; when the rats were pre-dosed with a 1/10^th human-equivalent dose of sildenafil/Viagra, the average number of erections increased to 4.6 and the time-to-initial-erection was approximately cut in half. This serves as proof-of-concept that Z-pod^™-delivered nitric oxide diffuses into the necessary compartments and significantly improves vasodilation.

Further, this work formed the basis of a $1,700,000 NIH Phase II SBIR grant submission titled “Development of microparticle-based topical treatments for treating erectile dysfunction in patients refractory to oral PDE5 inhibitors.” This past July, Zylö was awarded this grant and is now progressing towards the following aims:
(i) test other PDE5 inhibitors (Cialis^®, Levitra^®, Stendra^®), (ii) scale-up the manufacturing process and implement a cGMP quality program, (iii) conduct certain toxicity studies required for an Investigational New Drug [IND] application, and (iv) hold a pre-IND meeting with FDA to secure feedback critical to successful advancement of the program.

If approved, this Z-pod^™-based drug candidate will target two distinct market segments, as follows:

1. Men with ED secondary to radical prostatectomy: It has been reported that 86% of men that have undergone radical prostatectomy suffer from ED and there is currently no approved treatment available to them (just like with rats with severed cavernous nerves, these men do not respond to Viagra et al.).
2. Men with the more typical ED symptoms that either do not respond well to the PDE5 inhibitors or cannot use such drugs due to medication side-effects and/or interactions.

In the U.S. alone, these two market segments represent an addressable market of over $1 billion per year.

Andrew Draganski Ph.D. commented, “This award for Best Abstract by SMSNM acknowledges the potential breakthrough nature of Zylö’s nitric-oxide technology for the treatment of ED in men that are refractory to PDE5 inhibitors such as Viagra.”

About Zylö Therapeutics: Zylö has developed the Z-pod^™ technology platform, a disruptive delivery system using a matrix-style encapsulation to enhance bioavailability of both biologically active compounds in the pharmaceutical, animal health, and cosmetic industries. In addition, Zylö’s Z-pod^™ technology has the ability to effectively deliver nitric oxide, a powerful molecule that is critical for maintenance of human health. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).