Aequus Receives Approval from Health Canada to Initiate Phase 1 Clinical Trial of Aripiprazole Transdermal Patch
Vancouver, BC. November 16, 2015 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), announced today that it will initiate a Phase 1 clinical trial to evaluate the bioavailability and safety of Aequus’ once weekly transdermal patch for aripiprazole, AQS1301, following receipt of a No Objection Letter from Health Canada to the Company’s Clinical Trial Application. AQS1301 is designed to deliver aripiprazole (the active ingredient in Abilify ®) in a sustained and controlled manner for up to seven days in a single-patch application. Aripiprazole, an atypical antipsychotic, is a leading drug in the US, used for the treatment of a number of psychotic disorders including bipolar disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder.
“This is a major milestone for Aequus as we advance our lead development program into clinic and affirms our ability to meet anticipated development timelines.” said Doug Janzen, CEO and Chairman of Aequus.
“We believe there is a significant need for a multi-day, extended release formulation of aripiprazole that not only reduces the frequency of dosing for patients, but is delivered in a painless, non-invasive and easy to use delivery system, such as a transdermal patch.” said Anne Stevens, COO and Director. “The patch, unlike other multi-day delivery systems, can be safely and immediately removed in the event that an adverse event were to occur and provides assurance of compliance to caregivers who can visibly confirm the drug is being delivered. Both attributes are particularly important in children or those who may not consistently take their daily dosing.”
The first stage of the Phase 1 study is a double blinded, single-dose, randomized, placebo-controlled, seven day safety and bioavailability study of AQS1301 (once-weekly, transdermal aripiprazole), expected to enroll 12 healthy volunteers. The primary objective of the study is to assess the blood levels of aripiprazole over the seven day period with Aequus’ transdermal formulation. The secondary objectives are to assess safety and skin tolerability. The trial is expected to be initiated on December 1, 2015 and follows extensive preclinical evaluation in predictive in vitro human skin and in vivo animal models that demonstrated sustained delivery over a seven-day period. Aequus anticipates the clinical portion of this study will be completed by year-end, and the analysis to be completed in early 2016, which will be followed by a 28-day, multi-dose bioavailability study. The results from these studies are expected to inform any further optimization that may be required in the formulation as well as the design of the subsequent pivotal bioequivalence study.
The active ingredient in Aequus’ lead development program, AQS1301, is aripiprazole, which is currently marketed under the trade name Abilify ® as a once-daily oral tablet, and as Abilify Maintena ® as a once-monthly depot-injection. Abilify ® is a leading antipsychotic agent used worldwide for the treatment of bipolar I disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder.
Lack of adherence to antipsychotics is a serious issue that can lead to worsening of symptoms, relapse, suicidal attempts, repeated emergency room visits or re-hospitalization, and poor functional outcomes, particularly in schizophrenia. The rate of non-adherence to atypical antipsychotic medications in schizophrenia has been reported to be over 40%, of which, 69% have been shown to suffer a psychotic relapse. Similarly, non-compliance is a major problem in Bipolar I patients and is one of the highest contributing factors to relapse. Approximately 48% of Bipolar Disorder patients do not take their medication on the prescribed dosing schedule, which has substantial consequences in Bipolar Disorder as with each additional episode a patient suffers, the next is documented to be more frequent, more severe, and increasingly more difficult to treat.
A multi-day dosing alternative for aripiprazole is being developed by Aequus to address the challenge of patient compliance by improving ease of administration for patients.
Abilify ® is a registered trademark of Otsuka America Pharmaceutical, Inc.
Abilify Maintena ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
ABOUT AEQUUS PHARMACEUTICALS
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a Vancouver-based, specialty pharmaceutical company primarily 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 and to establish strategic partnerships to accelerate product development and maximize the reach of its product candidates worldwide. Through the recent acquisition of TeOra Health, Aequus now has a Canadian commercial platform to build on for the launch of 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.
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