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 Investor Relations
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This release contains forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this release include but are not limited to statements relating to: the implementation of our business model and strategic plans, the initiation and parameters of the Phase I clinical trial, the completion of the analysis of the Phase I clinical trial and the next steps in connection therewith. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to general business and economic conditions and the anticipated results of the Phase I clinical trial. In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Short-Form Prospectus dated June 30, 2015, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements.
Diclegis® and Diclectin® are registered trademarks of Duchesnay Inc.