Acerus Announces Initiation of a Phase 1 Clinical Trial with a Proprietary Intranasal Formulation of a Tetrahydrocannabinol-Rich Cannabis Oil

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (the “Company” or “Acerus”) (TSX:ASP) today announced first dosing of subjects in a Phase 1 clinical trial testing a proprietary intranasal formulation of a tetrahydrocannabinol (“THC”)-rich cannabis oil in healthy volunteers. This is a preliminary step in a broader strategy focused on identifying additional applications for Acerus’ proprietary nasal delivery technology, including for prescription medical marijuana.

“This clinical trial is an important milestone in our previously announced Cannabinoid Initiative,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “Our strategy is to develop a portfolio of THC and cannabidiol-based products that utilize our nasal gel delivery technology for use in a range of potential indications. The Company will generate evidence for the use of these products so that we can differentiate our products in the clinical and medical applications of cannabis. If successful, we will look to commercialize these products through partnerships or through our own efforts.”

“Smoking and oral ingestion are not optimal routes for cannabinoid administration, especially for medical marijuana users,” said Dr. Nathan Bryson, Chief Scientific Officer of Acerus Pharmaceuticals. “The nasal route of administration not only avoids first pass metabolism, it offers precise and consistent dosing, convenience and efficiency; benefits which may also apply to the delivery of THC. The unique clinical benefits of our proprietary nasal platform are gaining awareness and acceptance among patients and physicians, who are currently using Natesto^® to treat hypogonadism.”

The single-center trial will enroll 14 overnight-fasting, healthy subjects with prior cannabis experience who will each randomly receive one dose (5 mg) of cannabis oil orally and an equivalent dose of cannabis oil nasally, with one week separating the two treatments. Blood levels will be measured and pharmacokinetic parameters of absorption and elimination will be determined, along with comparative bioavailability of the active ingredient for the two routes of administration. Self-reported subject outcomes will also be collected. The results of the study will help determine whether the nasal route of administration allows for better and more reproducible absorption of cannabinoids by avoiding ingestion and first-pass liver metabolism. This study, for which Acerus has submitted a Clinical Trial Application, is being conducted by a third-party Clinical Research Organization in Canada.

About Acerus Pharmaceuticals Corporation

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 Toronto Stock Exchange under the symbol “ASP”. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice Regarding Forward-Looking Information

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, without limitation, with respect to the success of the Phase I clinical trial, the suitability of the nasal route of administration for absorption of THC, as well as the commercial potential of the products derived from Acerus’ cannabinoid initiative. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 20, 2018 that 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 laws.

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