Vancouver, BC. October 17, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that is has filed a Clinical Trial Application (CTA) with Health Canada for its once-weekly transdermal aripiprazole patch. Aequus has developed this product to provide patients with sustained and controlled delivery of aripiprazole in a convenient, weekly dosage form. Upon approval of the CTA, the Company plans to initiate a repeat dose, 28-day safety and bioavailability study of aripiprazole transdermal patches in eight healthy volunteers in late 2016.
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. Patient adherence to antipsychotic medication is a significant challenge, and presents an estimated 42% risk of relapsing following a missed dose. A seven-day application of aripiprazole is intended to provide patients with a convenient and easy to use long acting alternative and is expected to reduce the rate of relapse that may result from patients not adhering to their prescribed dosing schedule.
The currently planned study is a follow-on to the successfully completed single exposure proof of concept study, which suggested that the current formulation delivers sustained levels of therapeutic doses of aripiprazole over a seven day period. The planned repeat dose proof of concept study has a primary objective to assess the bioavailability of aripiprazole delivered in patch form after repeated administration in healthy volunteers. The secondary objective of the study is to assess the safety and tolerability of aripiprazole transdermal patch following repeated administration over a period of 4 weeks.
“We are very excited to see the continued advancement of this program,” said Dr. Don McAfee, Chief Scientific Officer at Aequus. “A seven-day patch that reliably delivers a sustained dose of aripiprazole has the potential to improve treatment adherence, reducing the risk of relapse associated with missed doses and reducing the burden of medicating in both home care settings and in institutions.”
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 and psychiatry 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 visit www.aequuspharma.ca.
FORWARD-LOOKING STATEMENT DISCLAIMER
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.