Aequus Receives Approval from Health Canada to Initiate Proof of Concept Clinical Trial of Anti-Nausea Patch
Vancouver, BC. July 5, 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 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.
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: the implementation of our business model and strategic plans, the initiation and parameters of the Proof of Concept clinical trial, the completion of the analysis of the Proof of Concept 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 Annual Information Form dated May 3, 2017, 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