Aequus Pharmaceuticals Inc. announced that it has received approval from Health Canada to initiate a multi-dose Proof of Concept clinical trial to evaluate the bioavailability and safety of Aequus' once-weekly transdermal patch for aripiprazole, AQS1301. The currently planned study is 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 is expected to commence on January 13, 2017, enrolling eight healthy male volunteers who will be dosed with four successive applications of a once-weekly patch. The company expects grant funding to cover up to half of the study costs, details of which will be announced in the coming weeks. Results are expected in first quarter of 2017 and will inform the final design of the patch to be used in the clinical trials necessary for regulatory approval. 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. 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 for regulatory approval in the US. After meeting with the FDA, Aequus expects to select potential partners to further develop the product and to commercialize the product, once approved.