Aequus Initiates Second Proof of Concept Clinical Trial of Transdermal Aripiprazole Patch
Vancouver, BC. January 9, 2017– Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), announced today that it has received approval from Health Canada to initiate a multi-dose Proof of Concept clinical trial to evaluate the bioavailability and safety of Aequus’ once-weekly transdermal patch for aripiprazole, AQS1301. The currently planned study is a follow-on to the successfully completed single-dose exposure proof of concept study which suggested that the current formulation delivers sustained levels of therapeutic doses of aripiprazole over a seven day period. This repeat dose, 28-day study is expected to commence on January 13, 2017, enrolling eight healthy male volunteers who will be dosed with four successive applications of a once-weekly patch. The Company expects grant funding to cover up to half of the study costs, details of which will be announced in the coming weeks. Results are expected in 1Q2017 and will inform the final design of the patch to be used in the clinical trials necessary for regulatory approval.
Aripiprazole is an atypical antipsychotic and the active ingredient in Abilify ®, a leading medication in the US used for the treatment of a number of psychiatric disorders including bipolar I disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder. Aripiprazole is currently available in once-daily oral tablets and a once-monthly injectable form, however, medication adherence continues to be a significant challenge for patients. Aequus has developed and owns global rights to a seven-day patch application of aripiprazole intended to provide patients with a convenient and easy to use long acting alternative, in an effort to reduce the rate of relapse that may result from patients not adhering to their prescribed dosing schedule.
Following the results of this study, Aequus anticipates meeting with the US Food and Drug Administration (FDA) for a pre-Investigational New Drug (pre-IND) meeting to define the clinical strategy for regulatory approval in the US. After meeting with the FDA, Aequus expects to select potential partners to further develop the product and to commercialize the product, once approved.
ABOUT AEQUUS PHARMACEUTICALS
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology, psychiatry and women’s health with a goal of addressing the need for improved medication adherence through enhanced delivery systems. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visitwww.aequuspharma.ca.
This release contains forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this release include but are not limited to statements relating to: the implementation of our business model and strategic plans, the initiation and parameters of the Phase I clinical trial, the completion of the analysis of the Phase I clinical trial and the next steps in connection therewith. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to general business and economic conditions and the anticipated results of the Phase I clinical trial. In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Short-Form Prospectus dated June 30, 2015, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements.
Abilify ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
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