Vancouver, BC. June 15, 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 is has filed a Clinical Trial Application (“CTA”) with Health Canada in preparation for a Proof of Concept clinical study for its long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine and doxylamine (the active ingredients in Diclegis ®/Diclectin ®). Upon approval of the CTA, which is expected in early July, the Company plans to initiate a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis ®/Diclectin ®, in nine healthy volunteers.
“We are very excited to see the continued advancement of this program,” said Anne Stevens, Chief Commercial Officer at Aequus. “A long-acting patch that reliably delivers a sustained dose of pyridoxine and doxylamine will benefit patients by reducing both the pill burden and maintaining a steady state of therapeutic delivery, while treating symptoms of nausea and vomiting.”
AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy (“NVP”). AQS1303 would 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. Currently, the oral form of Diclegis ® is the only FDA approved medication for morning sickness in pregnant women and in 2015 reached sales in the United States of approximately U.S.$120 million. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting) and to provide consistent and sustained symptomatic relief.
The primary objectives for the Proof of Concept study will be to assess the bioavailability, safety and tolerability of Aequus’ long-acting transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride. Study results are expected in Q3 2017, following approval of the CTA by Health Canada. 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. This 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.
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 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 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.