Aequus Pharmaceuticals Inc. (TSXV: AQS) is initiating a Proof of Concept clinical trial of its anti-nausea patch
SmallCapPower | July 6, 2017: Aequus Pharmaceuticals Inc. (TSXV: AQS), a specialty pharmaceutical company focused on developing and commercializing differentiated products for unmet medical needs, announced on July 4, 2017, that it has received Health Canada approval for initiating a Proof of Concept clinical trial for its pipeline product AQS1303, a long-acting transdermal anti-nausea patch containing combination of pyridoxine and doxylamine, the active ingredients in the approved oral version Diclegis marketed by Duchesnay USA. The single-dose cross-over comparative bioavailability study versus the oral version of the drug Diclegis in nine healthy volunteers will be completed by the end of 2Q17. Concurrently Aequus is preparing for a pre-Investigational New Drug meeting with the U.S. FDA and plans to follow a 505(b)(2) pathway, an abbreviated clinical pathway that allows the Company to reference safety and efficacy data of the original oral tablet form of the medication.
This is the second proof of concept study for the Company’s four development pipeline products, which are all transdermal formulations of drugs. AQS1301, once-weekly transdermal formulation of aripiprazole, successfully completed Two Proof of Concept clinical studies and is due for a Pre-IND meeting for potential approval in the U.S. The Company currently markets two (TACROLIMUS IR and VISTITAN) products in Canada and has two Epilepsy products in pre-registration stage in Canada.
Nausea and Vomiting of Pregnancy (NVP), most commonly known as “morning sickness,” affects ~53% of women and Pyridoxine/doxylamine currently marketed as Diclegis® (US)/Diclecitin® (Canada) is the first-line therapy and the only on-label intervention for this indication. However this oral form needs to be dosed up to four times per day, causing gag reflexes in women. Hence there is a large and unmet need for an alternative delivery system. If approved, Aequus’ transversal could capture a sizable portion of the oral Diclegis market, which the Company estimates at $120 million in 2015. Aequus reported ~$0.7 million revenues for 2016 and the approval of the AQS1301 and the AQS1303 products could drive revenues going forward. The Company currently trades at price to ttm sales of ~18.24x compared to the pharmaceutical industry average of ~4.0x.
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