Vancouver, BC. February 4, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), announced today positive results from an initial bioavailability study of its lead development program, AQS1301, a once-weekly transdermal form of aripiprazole. 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. 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.
This initial clinical study was conducted in a single trial site in Canada, and was completed in late December, 2015. The study was designed as a double blinded, single-dose, randomized, placebo-controlled, seven-day safety and bioavailability study, enrolling 12 healthy volunteers. The primary objective of the study was to assess the blood levels of aripiprazole over the seven-day period with Aequus’ transdermal formulation. The results were remarkably consistent and suggest that sustained, seven-day delivery of therapeutic doses of aripiprazole is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported and minimal skin irritation seen at the application site. The formulation is now expected to be advanced into the second stage of this proof of concept study, which will be a 28-day, multi-dose bioavailability study to be initiated during the first half of 2016. The results from these two proof of concept studies will inform any further optimization that may be required in the patch as well as the design of the subsequent pivotal bioequivalence study.
Aequus’ transdermal aripiprazole product is being developed as part of a previously announced collaboration with Corium International, Inc., a leading company in the field of transdermal drug development and manufacturing. Corium has worked with Aequus to optimize the formulation of the product and produced the clinical trial materials used in the recent study.
“We are very pleased with these results, as it demonstrates that the formulation is safe and that it is feasible to engage in a multi-dosing trial lasting several weeks.” said Don McAfee, Chief Scientific Officer at Aequus.
“We look forward to continued progress from our aripiprazole program in 2016 as we continue to advance this and our other two development programs into clinical trials,” said Doug Janzen, Chairman and CEO of Aequus.
Aequus is also developing two additional long acting patches, one for the treatment nausea and vomiting in first trimester pregnancy, and the second for the treatment of a rare form of epilepsy. Both programs are expected to enter proof of concept clinical trials later this year.
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 adherence by improving ease of administration for patients.
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.