The product concept uses a patent-waiting for Z-podsâ¢ to sustainably-for more than an hour-release nitric oxide
GREENVILLE, SC, Nov. 10, 2021 (GLOBE NEWSWIRE) – A new nitric oxide-releasing product concept developed by ZylÃ¶ Therapeutics received the Best Abstract – Basic Science Award at the Annual Scientific Meeting of the North American Society for Sexual Medicine of North America (SMSNA), which was 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 MD of the Albert Einstein College of Medicine and was co-authored by Andrew Draganski Ph.D., director of product development at ZylÃ¶, and Kelvin Davies Ph.D., professor of urology and professor of physiology and biophysics at Einstein College.
This work, funded by a $ 225,000 grant from NIH STTR, demonstrated convincing results in a rat model of radical prostatectomy of DE. In this model, the rat cavernous nerve is surgically severed so that the rat is sexually dysfunctional and does not respond to sildenafil (a.k.a. ViagraÂ®) and other PDE5 inhibitors. After a single topical application of Z-pod releasing nitric oxideâ¢ formulation, rats experienced 2.0 erections on average during the 60 minute observation period immediately after administration; when the rats were pre-dosed with a 1/10e human equivalent dose of sildenafil / Viagra, the average number of erections was reduced to 4.6 and the time to initial erection was approximately halved. This serves as a proof of concept that the Z-podâ¢the nitrogen monoxide delivered diffuses into the necessary compartments and significantly improves vasodilation.
In addition, this work formed the basis of a $ 1,700,000 NIH Phase II SBIR grant submission titled “Development of Topical Microparticle Therapies for the Treatment of Erectile Dysfunction in Patients Refractory to Oral Inhibitors. PDE5 â. Last July, ZylÃ¶ was awarded this scholarship and is now making progress towards the following goals:
(i) test other PDE5 inhibitors (CialisÂ®, LevitraÂ®, StendraÂ®), (ii) intensify the manufacturing process and implement a cGMP quality program, (iii) conduct certain toxicity studies required for a new investigational drug [IND] request, and (iv) hold a pre-IND meeting with the FDA to obtain feedback critical to the successful advancement of the program.
If approved, this Z-podâ¢The drug candidate will target two distinct market segments, as follows:
- Men with erectile dysfunction secondary to radical prostatectomy: It has been reported that 86% of men who have had radical prostatectomy suffer from erectile dysfunction and there is currently no approved treatment for them (just like with rats with nerves cavernous severed, these men do not respond to Viagra et al.).
- Men with the most typical symptoms of erectile dysfunction who do not respond well to PDE5 inhibitors or cannot use such drugs due to side effects and / or drug interactions.
In the United States alone, these two market segments represent an addressable market of over $ 1 billion per year.
Andrew Draganski Ph.D. commented: âThis SMSNM Best Abstract Award recognizes the potentially revolutionary nature of ZylÃ¶’s nitric oxide technology for the treatment of erectile dysfunction in men refractory to PDE5 inhibitors such as Viagra. “
About ZylÃ¶ Therapeutics: ZylÃ¶ developed the Z-podâ¢ technology platform, a disruptive delivery system using matrix-type encapsulation to improve the bioavailability of the two biologically active compounds in the pharmaceutical, animal health and cosmetic industries. In addition, ZylÃ¶’s Z-podâ¢ The technology has the ability to efficiently deliver nitric oxide, a potent molecule that is essential for the maintenance of human health. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).