Vancouver, BC. September 7, 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 positive results from an initial Proof of Concept clinical study for its long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine hydrochloride and doxylamine succinate (the active ingredients in Diclegis®/Diclectin®). This single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
We are greatly encouraged by the results of this initial Proof of Concept clinical study and believe the study clearly demonstrated the feasibility of a fixed dose combination patch containing doxylamine and pyridoxine for the treatment of nausea and vomiting of pregnancy,â€ said Don McAfee, Chief Scientific Officer of Aequus.
We are very excited about the potential for this product and these initial results bring us one step closer to providing an elegant solution for pregnant women suffering from nausea and vomiting,â€ said Doug Janzen, CEO and Chairman of Aequus. â€œWe look forward to the continued advancement of this program and will be engaging with both potential partners and the FDA over the coming months.â€
AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy (â€œNVPâ€). 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 DiclegisÂ® 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, according to IMS data. 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 was to assess the bioavailability, safety and tolerability of Aequus’ long-acting transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride compared to that of a single oral dose of Diclegis®. Aequus will incorporate the results from this study into a pre-Investigational New Drug (pre-IND) submission 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
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: expected benefits of AQS1303 and transdermal delivery, the further advancement of AQS1303, and the Company’s ability to form strategic partnerships for its internal programs. 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.
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