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Acerus Announces Publication of Manuscript Reporting Early Data from Partner-Sponsored Natesto® Spermatogenesis Study

09/17/2018

-- Early Data SuggestsSperm Concentration, Motility, and Total Motile Sperm Count Remain Within Normal Ranges in Hypogonadal Men Taking Natesto® --

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX: ASP) (“Acerus” or the “Company”) today announced the publication of a clinical trial update in the journal European Urology Focus on the effects of Natesto® on reproductive hormones and semen 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. The Company’s partner, Aytu BioScience Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, is sponsoring this investigator-initiated trial.

The publication, titled “Natesto Effects on Reproductive Hormones and Semen Parameters: Results from an Ongoing Single-center, Investigator-initiated Phase IV Clinical Trial”, provides updated data on five of the 23 currently enrolled subjects, through six months of Natesto® treatment. Testosterone therapy (TTh), as a whole, is known to decrease gonadotropin levels, diminish sperm production and function, and decrease the natural production of endogenous testosterone in men being treated with TTh. Maintenance of fertility and family planning is an important consideration before initiating TTh; therefore, the effects of Natesto® may provide physicians with a unique approach for treating men with hypogonadism.

After both three months and six months of Natesto® therapy, there were no statistically significant changes in sperm concentration, sperm motility, and total motile sperm count from baseline in the five patients being reported on. Median total motile sperm count (TMSC) were slightly, but not significantly, reduced from 37.5 million at baseline to 32.5 million after six months of Natesto® therapy. Additionally, four out of five men had total testosterone levels above 300 ng/dL, median 654.0 (389.5 - 810.3) ng/dL. Gonadotropin levels for luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were reduced, but remained within the normal reference range.

“About two million men in the US with low testosterone are young and interested in maintaining their fertility,” said Dr. Ranjith Ramasamy, the study’s principal investigator. “The current options to increase testosterone and simultaneously maintain sperm production are not FDA-approved and therefore need to be used off-label. The initial results from the trial with Natesto® are exciting, and we are optimistic that the final results will be similar to the preliminary data. Increasing testosterone levels while maintaining fertility with Natesto®, if borne out by the final results, could be a paradigm-shift in treatment of men with low testosterone.”

“Should these early results bear out through the balance of the study, they could suggest a potentially unique role for Natesto® as a treatment option for men who wish to preserve their fertility and gonadotropin function while being treated for hypogonadism,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “We continue to work collaboratively with our partner to understand fully all the benefits that Natesto® can offer patients, including those that could help differentiate our product in the marketplace. We appreciate Dr. Ramasamy’s leadership in conducting this study and expect to report additional results as they become available.”

To read the published article, please visit https://www.eu-focus.europeanurology.com/article/S2405-4569(18)30228-1/fulltext.

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

About Natesto ®  (Testosterone) Nasal Gel

Natesto® is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. FDA, Health Canada and South Korea and available in a ‘no-touch’ dispenser with a metered dose pump. A copy of the NATESTO® Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO®.com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve patient experience, with a primary focus in the field of men’s and women’s health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.

Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties and could differ materially from what is currently expected as set out above, including with respect to the final results of the Natesto® spermatogenesis study and the possible effects of Natesto® on sperm concentration, motility, and total motile sperm count remain. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 20, 2018 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

Tricia Symmes
Chief Operating Officer
Acerus Pharmaceuticals Corporation
tsymmes@ceruspharma.com
(416) 509-2116

Source: Acerus Pharmaceuticals Corporation