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SAN DIEGO - Aardvark Therapeutics, Inc. (NASDAQ:AARD), a $242 million market cap biotech company with a strong financial health score according to InvestingPro, announced Tuesday that its investigational drug ARD-201 demonstrated approximately 19% body weight reduction in diet-induced obese mice after 30 days of treatment.
The preclinical study showed ARD-201 helped attenuate weight regain after discontinuation of tirzepatide, a GLP-1 receptor agonist. When combined with low-dose tirzepatide, ARD-201 improved weight loss compared to high-dose tirzepatide alone, according to the company’s press release.
ARD-201 is an oral combination of a DPP4 inhibitor and ARD-101, a gut-restricted molecule that activates taste receptors involved in hunger regulation. The drug is designed to stimulate the release of satiety hormones and extend their activity.
"Weight maintenance remains a major challenge for many patients seeking an off-ramp from treatment with GLP-1RA therapies," said Timothy Kieffer, Chief Scientific Officer at Aardvark.
Based on these results, Aardvark plans to advance ARD-201 into two Phase 2 clinical trials. Trading at $11.15, with analyst targets ranging from $20 to $50, the company maintains a robust current ratio of 25.86 and holds more cash than debt. The POWER trial, expected to begin in the second half of 2025, will evaluate the drug’s potential to prevent weight regain in subjects who discontinue GLP-1RA therapy. The STRENGTH trial, planned for early 2026, will assess weight loss with ARD-201 alone and in combination with GLP-1RA therapy.
These trials will replace the previously planned EMPOWER trial, the company stated.
Aardvark is also developing ARD-101 as a standalone treatment for hyperphagia associated with Prader-Willi Syndrome in a Phase 3 trial.
The company plans to submit details of the preclinical study for peer review publication. With its next earnings report due in 22 days, investors can access comprehensive financial analysis and additional insights through InvestingPro, which offers 8 more exclusive tips about AARD’s financial position and growth prospects.
In other recent news, Aardvark Therapeutics has undergone a significant leadership reorganization. This shift comes as the company continues its Phase 3 HERO study for ARD-101, a treatment aimed at addressing hyperphagia in Prader-Willi Syndrome. Newly appointed executives include Timothy Kieffer, Ph.D., as Chief Scientific Officer and Danny Villeneuve as Chief Commercial Officer, among others. This strategic reshuffle is intended to support the company’s ongoing programs. Additionally, H.C. Wainwright has initiated coverage on Aardvark Therapeutics with a Buy rating and set a price target of $40.00. The firm noted Aardvark’s innovative approach to treating obesity and hyperphagic conditions through its lead candidate, ARD-101. These recent developments highlight the company’s focus on advancing its clinical and commercial objectives.
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