Aequus Receives Approval from Health Canada to Initiate Phase 1 Clinical Trial of Aripiprazole Transdermal Patch

Nov 16, 2015

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.


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

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