San Diego, Calif., October 15th, 2020 – Aardvark Therapeutics, Inc. announces completion of the first cohort in a Phase 1 clinical trial of ARD-101. This is a first-in-human, randomized, double-blind, placebo-controlled, dose escalation study. The study is evaluating oral ARD-101 for safety, tolerability, pharmacokinetics, and exploratory biomarkers in healthy human volunteers. No adverse events were reported. The study is proceeding as planned with the next cohort testing a higher dose.
ARD-101 is an oral, first-in-class therapeutic. Preclinical studies of ARD-101 have shown promising activity in models of acute and chronic inflammation, as well as metabolic disorders.
“The successful completion of the first cohort in this clinical trial of ARD-101 is an important milestone in Aardvark’s development program. It takes us one step closer to advancing a first-in-class drug with novel mechanisms of action,” said Dr. Tien Lee, Chief Executive Officer of Aardvark Therapeutics, Inc.”We look forward to the early data to guide our future clinical development plans”.
About Aardvark Therapeutics, Inc.:
Aardvark Therapeutics is a biotechnology company focused on the development of novel small molecule therapeutics for inflammation, metabolic diseases, and other indications.
Forward Looking Statements
This press release contains, in addition to historical information, statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding our plans, expectations and goals regarding the clinical trial, our future development plans, and the potential benefits of ARD-101 in multiple clinical indication. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trial are subject to factors beyond our control. Our clinical trial may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. In regard to our clinical trial, we may have difficulty in enrolling candidates for testing, which would impact our estimates regarding timing, and we may not be able to achieve the desired results. Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse impact on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including ARD-101, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements. SOURCE Aardvark Therapeutics, Inc.
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