Vancouver, BC - May 28, 2015 - Aequus Pharmaceuticals, Inc., “Aequus” (TSX-V: AQS), announced today they have received positive skin irritation results in animal studies for their lead program, AQS-1301, a once-weekly transdermal formulation of aripiprazole. The formulation will be advanced into a comprehensive animal pharmacokinetic study in June which is expected to confirm that the transdermal patch is delivering target levels of drug. The results from these studies will then inform the Proof of Concept clinical trial in humans which is expected in the second half of 2015.
“We are very encouraged by the progress being made on AQS-1301,” said Dr. Don McAfee, Chief Scientific Officer of Aequus. “These skin irritation studies give us confidence that we are on the right track to manufacture a skin patch that will safely deliver sufficient amount of drug to treat patients with psychiatric disorders.”
The oral, once-daily formulation of aripiprazole is currently marketed under the trade name Abilify, which is an atypical antipsychotic, used for the treatment of bipolar I disorder, schizophrenia, irritability associated with autistic disorder, and major depressive disorder. Abilify is a market leader in the U.S., and Aequus believes it has limitations due to its daily dosing regimen which is associated with frequent missed doses and subsequent risk of relapse. Aequus’ proposed transdermal, once-weekly aripiprazole patch is designed to deliver aripiprazole consistently over a seven-day period at levels equivalent to currently marketed once-daily formulations. By delivering aripiprazole over seven days in a comfortable, convenient, easy-to-monitor and easy-to-use weekly patch, AQS-1301 is intended to promote enhanced medication adherence.
ABOUT AEQUUS PHARMACEUTICALS
Aequus Pharmaceuticals Inc. is a Vancouver-based specialty pharmaceutical company focused on enhancing delivery methods for approved drugs that are limited by non-compliance, high frequency dosing, first-pass metabolism side-effects, painful injections, or where the therapeutic profile can be improved by making a long-acting alternative available. Aequus’ early-stage pipeline is focused on neurology and psychiatry products where there is a high medical need for an alternate route of delivery. Aequus’ lead-program, AQS-1301, is a once-weekly transdermal formulation of aripiprazole in development for the potential treatment of irritability associated with autistic disorder, bipolar disorder, schizophrenia, and major depressive disorder. AQS-1301 is currently in pre-clinical development and will be entering Proof of Concept clinical studies in the second half of 2015. For further information, please visit www.aequuspharma.ca.
FORWARD-LOOKING STATEMENT DISCLAIMER
This release may contain 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 include but are not limited to statements relating to: the implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launches; the Company’s expected revenues; the regulatory approval of its products; the Company’s ability to attract international partners; and ongoing discussions with and the Company’s ability to secure potential partners to further grow our product portfolio. 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: obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully out license or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; the impact of the coronavirus (COVID-19) on the Company’s operations; and the Company’s ability to protect patents and proprietary rights. 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 April 30, 2021, 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.