Zylö Receives $1,700,000 NIH Phase II Grant to Advance Erectile Dysfunction Program into Human Trials

Funds to be used for scale-up, implementation of cGMP quality system, and pre-IND FDA meeting

GREENVILLE, SC, July 20, 2021 (GLOBE NEWSWIRE) -- Zylö Therapeutics Inc., developer of the transformational Z-pod^™ topical delivery platform, has been awarded a $1,700,000 Small Business Innovation Research (SBIR) grant to advance Zylö’s proprietary nitric-oxide-releasing topical drug candidate into clinical trials. The grant, titled “Development of microparticle-based topical treatments for treating erectile dysfunction [‘ED’] in patients refractory to oral PDE5 inhibitors,” was 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 of urology and professor of physiology and biophysics at Albert Einstein College of Medicine.

Using ~$225,000 of NIH funds from a Phase I award, Zylö demonstrated compelling results in a radical prostatectomy rat model of ED, whereby 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. With 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 topical 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.

The goal of this Phase II work is to (i) test other PDE5 inhibitors (Cialis^®, Levitra^®, Stendra^®), (ii) scale-up the manufacturing process and to overlay a cGMP quality program, (iii) conduct certain toxicity testing required for an Investigational New Drug [IND] application, and (iv) hold a pre-IND meeting with the FDA to secure feedback critical to successful development of the program.

If eventually 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 (which typically impacts the cavernous nerve) will suffer from ED, with 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 ‘age-related’ ED symptoms that either do not respond well to the PDE5 inhibitors or cannot take the medication due to medication side-effects or drug interactions.

In the U.S. alone, these two market segments represent an addressable market of over $2 billion per year.

Andrew Draganski Ph.D. commented, “Zylö’s nitric-oxide technology is a potential breakthrough in the treatment of ED in men that are refractory to the PDE5 inhibitors such as Viagra. This commitment by the National Institute of Diabetes and Digestives and Kidney Diseases is quite validating, and we are grateful to the NIDDK for their funding.”

Added Jay Blankenship MD, Zylö’s head of business 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 ED, but for a myriad of other clinical applications such as wound-healing, atopic dermatitis, gingivitis, and sports recovery.”

About Zylö Therapeutics: Zylö has developed the Z-pod^™ technology platform, a disruptive topical delivery system that extends the duration of effect, improves the solubility/targeting, and enhances the product performance of many therapeutic and cosmetic agents. Notably, the Z-pod^™ technology has successfully harnessed the therapeutic potential of nitric oxide, one of the most powerful—and short-lived—biomolecules produced by our bodies. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).