Vancouver, BC. April 3, 2017– Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), today announced results from its second Proof of Concept study designed to evaluate the pharmacokinetics (PK), safety and tolerability following repeat exposure of its once-weekly aripiprazole transdermal patch, AQS1301, for the treatment of certain psychiatric disorders. Aripiprazole is among the most commonly prescribed anti-psychotics globally under the trade name Abilify®, however the once-daily oral delivery system of Abilify® can be limited by low rates of patient adherence. Aequus’ market research involving over 250 psychiatrists indicates that up to 42% of patients in certain populations experience a relapse at least once a year due to non-adherence to their oral medication. These physicians provided strong feedback around the need for a non-invasive, long-acting alternative to this important medication, such as a once-weekly patch.
The purpose of this multi-dose study was to evaluate the bioavailability of AQS1301 following four weeks of exposure in order to establish steady state plasma levels. This was achieved in healthy male volunteers aged 45-65. As predicted, steady state of the current formulation was reached in week three of dosing, with relative concentrations of aripiprazole and its active metabolite, dehydroaripiprazole, comparable to oral dosing of Abilify®. There were no serious adverse events or safety concerns.
“We are pleased that results from the study met our expectations,” said Doug Janzen, President and CEO at Aequus. “We continue to work with patient groups and physicians to ensure the commercial presentation of our product meets the needs of the patient populations that we have identified as the best suited potential candidates for a transdermal patch, namely major depressive disorder in elderly patients in a homecare setting, autistic patients suffering from irritability, as well as newly diagnosed and mild bipolar patients.”
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 and path forward for regulatory approval in the US.
The multi-dose Proof of Concept clinical trial was intended to evaluate the bioavailability and safety of Aequus’ once-weekly transdermal patch for aripiprazole, AQS1301. The study was 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 enrolled eight healthy male volunteers who were dosed with four successive applications of a once-weekly patch followed by a wash out period. One subject was removed for protocol violation during the study period, seven subjects completed the study. Blood samples for both aripiprazole and dehydroaripiprazole were drawn, and the plasma concentrations compared against published PK profiles for both the oral and once-monthly injectable formulations.
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.
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a 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 visit www.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 and the next steps in connection with AQS1301 following the Proof of Concept clinical trial results. 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.