Aequus Receives Approval from Health Canada to Initiate Proof of Concept Clinical Trial of Anti-Nausea Patch
VANCOUVER, BC --(Marketwired - July 05, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: 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 received approval from Health Canada to initiate a Proof of Concept clinical trial to evaluate the bioavailability and safety of Aequus' long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®). AQS1303 is designed to provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day.
As previously announced, this first Proof of Concept study will be a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, in nine healthy volunteers. Results from this study are expected to be released by the end of this current quarter.
"Diclegis®/Diclectin® has provided symptomatic relief to millions of women to date, but in its current form it is dosed orally multiple times per day which can induce gag reflexes in women experiencing nausea during pregnancy," said Anne Stevens, Chief Operating Officer and Director at Aequus. "We are very excited about the potential for this program and believe a long-acting patch could provide a much needed solution for this medication, giving patients a more comfortable and convenient dosing alternative."
In parallel to this study, Aequus is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. The product is expected to follow a Section 505(b)2 New Drug Application (NDA), an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication. Aequus owns the global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
Additionally, the Company issued Camargo Pharmaceutical Services, LLC 80,676 common shares on June 27, 2017 in connection with a service agreement to provide regulatory consulting services for the Company's product development programs in the United States.
