Vancouver, BC. February 14, 2017– Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has completed the treatment phase of its multi-dose Proof of Concept clinical trial evaluating the bioavailability and safety of its once-weekly transdermal patch for aripiprazole, AQS1301. 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. Aequus’ novel once-weekly formulation is designed to provide patients with an easy to use and convenient long-acting alternative to the once a day oral pill. The Company expects to report topline results from this multi-dose study in the first quarter of 2017.
“We look forward to announcing the results of this study, which we expect will provide a solid basis for advancing AQS1301 through an initial meeting with the FDA regarding the clinical path to approval in the United States, as well as continued advancement in partnership discussions for this program,” said Anne Stevens, COO and Director of Aequus. “The single-dose exposure study previously completed in 2016 demonstrated the potential for our formulation to provide sustained and controlled delivery of aripiprazole over seven days in therapeutic doses. This study will provide information that will enable us and our development partner, Corium International, to finalize the design of the transdermal patch that we would advance into late stage clinical studies.”
This 28-day, multi-dose Proof of Concept study was supported by a grant of up to $100,000 from the National Research Council of Canada Industrial Research Assistance Program (“NRC-IRAP”).
Aequus anticipates meeting with the US FDA following the results of this study 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.
Aripiprazole is an atypical antipsychotic, 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 growing 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.