Aytu BioScience Announces Publication of Clinical Study Results Demonstrating Effectiveness of Natesto(R) Regardless of Patients’ Baseline Hypogonadism Severity

First Natesto Study to Demonstrate Efficacy in Severely Hypogonadal Patients

ENGLEWOOD, CO / ACCESSWIRE / July 8, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today the acceptance of a new manuscript submitted to the Journal of the Endocrine Society, demonstrating that Natesto® achieves similar symptom improvement, regardless of the degree of patients’ testosterone deficiency, while maintaining function of the Hypothalamic-Pituitary-Gonadal (HPG) axis in hypogonadal men.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, “With the publication of this study, entitled Efficacy of Nasal Testosterone Gel (Natesto) Stratified by Baseline Endogenous Testosterone Levels, we now have clear evidence that Natesto is effective for a wide range of hypogonadal patients regardless of the degree of their baseline hypogonadism. The body of clinical evidence supporting Natesto’s unique efficacy and safety profile continues to grow, and we believe these new data in conjunction with the previously published and ongoing studies stand to further differentiate Natesto from the other testosterone replacement therapies.”

This new scientific report describes a post-hoc analysis of data from the pivotal Phase 3 study of Natesto, which enrolled 306 patients from 52 sites in the United States, who were treated with Natesto for up to one year. Patient data from the Phase 3 study were classified based on the degree of testosterone deficiency demonstrated by patients at study entry. Each dose of Natesto resulted in a short-term return of testosterone to the upper normal range (800 ng/dL) irrespective of how low the patient’s baseline testosterone was prior to the study.

Additionally, in the patient group with the lowest baseline testosterone level, a mean average serum testosterone level of 295 ng/dL was achieved with Natesto exposure. Statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients.

In between Natesto doses, all patients in the phase 3 study maintained their natural testosterone at the same levels they had prior to entry into the study, indicating that Natesto does not suppress natural testosterone production. A unique mechanism of action is proposed whereby the peaks in testosterone generated by Natesto dosing provide efficacy and improvement of symptoms, while time between doses (4-8 hours) allows for recovery of the HPG axis as well as continued LH secretion which maintains testicular testosterone production and FSH secretion which stimulates sperm production.

“The pharmacology of Natesto is unique from other testosterone products that treat low testosterone or hypogonadism,” says Dr. Ethan Grober, Associate Professor, Division of Urology, University of Toronto and the one of the new study’s authors. “The release of testosterone with Natesto is pulsatile – closely matching the bodies “natural” testosterone release. Consequently, Natesto does not suppress a man’s natural testosterone level, but simply adds to it to achieve a normal, safe level of testosterone. Furthermore, Natesto has been shown to work even in severely testosterone deficient patients suggesting that a wide range of testosterone deficient patients can be effectively treated.”

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, the only FDA-approved oral spray prescription sleep aid. ZolpiMist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ”may,” ”will,” ”should,” ”forecast,” ”could,” ”expect,” ”suggest,” ”believe,” ”estimate,” ”continue,” ”anticipate,” ”intend,” ”plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future revenue growth, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ”Risk Factors” in Part I, Item 1A of Aytu BioScience, Inc.’s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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SOURCE: Aytu BioScience, Inc.

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