Aytu BioScience Provides Study Update for Spermatogenesis Study of Natesto (R), the Only FDA-Approved, Nasally-Administered Testosterone Treatment

Interim Results Demonstrated Preservation of Sperm Parameters After Six Months of Treatment with Nasally-Administered Natesto Testosterone Gel

Natesto Spermatogenesis Study Presentation Awarded Presidential Citation at ENDO 2019 Scientific Meeting

ENGLEWOOD, CO / ACCESSWIRE / March 27, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, is providing an enrollment update for the ongoing Natesto Spermatogenesis Study, the Phase 4 clinical trial investigating the impact of nasally-administered Natesto on preservation of fertility parameters. This study is being conducted at the University of Miami’s Department of Urology, and Dr. Ranjith Ramasamy, MD, the Director of Reproductive Urology, is the study’s principal investigator.

To date, 56 patients have been enrolled in the study, and 15 subjects have completed treatment at six months. Interim results published to date demonstrate that all three measured fertility parameters are preserved after three and six months of Natesto treatment.

Additionally, the presentation of the Natesto Spermatogenesis Study was awarded with a Presidential citation at the 101st Annual Endocrine Society Meeting held March 23-26 in New Orleans, LA. Lead author and University of Miami urology chief resident Tom Masterson, MD presented interim data for the ongoing study and received the Presidential citation. The Presidential Poster Competition awards presenting fellows and trainees for research excellence and impact of the research in the field of endocrinology.

The Natesto Spermatogenesis Study is investigating the impact of Natesto, the only FDA approved, nasally-administered testosterone treatment, on sperm production. This single-site, prospective study is evaluating hypogonadal men, ages 18 to 55, completing a six-month treatment period with Natesto to restore clinically low serum testosterone levels with the goal of maintaining sperm concentration, motility, and total motile sperm count.

Of the 56 subjects enrolled to date, 43 subjects have completed one month of Natesto therapy, 23 subjects have completed three months, and 15 subjects have completed the full six-month treatment period equivalent to two rounds of spermatogenesis.

Interim results demonstrate that subjects completing the six-month treatment period not only had serum testosterone levels return to the normal range, but all measures of semen parameters including sperm concentration, sperm motility, and total motile sperm count (TMSC) remained statistically unchanged through three months and six months of therapy.

Traditional testosterone replacement therapy (TRT), as a whole, has been known to decrease gonadotropin levels, diminish sperm production and function, and decrease the natural production of endogenous testosterone in men being treated with TRT. Maintenance of fertility and family planning is an important discussion topic for the more than 2 million men considering testosterone replacement therapy. Therefore, the effect of Natesto possibly minimizing the impact on sperm production would be clinically impactful and novel by providing a safe and effective approach for treating men with hypogonadism.

Josh Disbrow, Aytu BioScience’s Chief Executive Officer commented, ”We congratulate Dr. Masterson, Dr. Ramasamy, and their entire research group for receiving the prestigious Presidential citation at ENDO 2019 for their ongoing work with the Natesto Spermatogenesis Study. Their work surrounding Natesto is exciting, and these data may represent a true paradigm shift in how clinicians treat Low T. We’re encouraged by the positive results to date demonstrating preservation of fertility parameters with Natesto. Further, it is encouraging to see the high level of patient enrollment achieved to date in this novel study. We’re looking forward to observing Dr. Ramasamy’s group’s continued progress with this study and seeing the final results this summer.”

The entire study group is expected to complete the full six-month treatment period during summer 2019, and the full data will be reported soon thereafter.

Interim results were previously published in August 2018 in European Urology Focus.

Aytu BioScience is sponsoring this investigator-initiated trial, and complete details on the study can be found at https://clinicaltrials.gov/ct2/show/NCT03203681?term=Natesto&rank=4

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical 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™, an FDA-approved, commercial-stage prescription sleep aid 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. 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, growing 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 the completion and final results of the Natesto Spermatogenesis Study, 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 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 the Company’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.

SOURCE: Aytu BioScience, Inc.

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