Aardvark Therapeutics has halted two mid-stage clinical studies evaluating its oral obesity candidate ARD-201, extending a series of recent program suspensions tied to safety findings associated with its lead molecule, ARD-101. The decision follows an earlier pause of a Phase 3 trial involving ARD-101 and leaves all of the company’s active development programs on hold.
The two paused Phase 2 studies, POWER and STRENGTH, were designed to assess ARD-201 in different treatment settings. The POWER trial was examining the drug’s ability to maintain weight loss in patients who had already reduced at least 15% of their body weight using GLP-1 therapies. Meanwhile, the STRENGTH study was evaluating ARD-201 in combination with a GLP-1 drug to determine whether it could enhance weight reduction outcomes. Both trials were initially announced in August following preclinical data that supported further investigation.
Aardvark stated in its March 23 earnings release that the suspension is part of a broader effort to review available data on ARD-201. The candidate combines ARD-101, a gut-targeting taste receptor agonist, with a dipeptidyl peptidase-4 inhibitor intended to prolong the activity of hormones such as GLP-1. ARD-101 works by stimulating enteroendocrine cells in the digestive tract, triggering the release of GLP-1 and cholecystokinin to reduce hunger and increase feelings of fullness.
The reassessment of ARD-201 follows safety observations linked to ARD-101. In a healthy volunteer study, two participants receiving doses above the intended therapeutic range exhibited echocardiographic changes that could indicate reduced cardiac efficiency. These findings were described as reversible, but they prompted the company to suspend dosing and enrollment in the Phase 3 HERO trial for Prader-Willi syndrome, a rare genetic disorder characterized by persistent hunger.
Aardvark noted that the doses associated with the cardiac observations were 1,600 mg administered twice daily without prior dose escalation, representing twice the target dose used in the HERO study. The safety study itself was conducted as part of standard requirements to support a future regulatory submission.
William Blair analysts indicated that these findings could have broader implications for the ARD-101 program. In a March 24 note, they stated that the observed cardiac events may be related to the mechanism of action and could affect the drug’s therapeutic margin. The analysts also suggested that the Phase 3 pause could create an opportunity for early unblinding of study data, depending on discussions with the U.S. Food and Drug Administration, potentially allowing for earlier evaluation of efficacy signals.
Company leadership emphasized that patient safety remains central to its decision-making. Aardvark founder and CEO Tien Lee said, “We are actively engaging with the FDA with urgency to determine the best path forward for our programs.”
The suspension of ARD-201 trials represents a shift from earlier expectations. As recently as December, William Blair analysts had pointed to the drug’s potential as an oral alternative to existing GLP-1 therapies, highlighting its possible use in both weight-loss initiation and maintenance settings.
The recent developments have coincided with a significant decline in Aardvark’s market value. Following the earlier Phase 3 suspension, the company’s share price dropped sharply and has continued to trend downward. After trading near $16 per share following its $94 million initial public offering last year, the stock closed at $4.06 on Monday and was down more than 69% year-to-date.
Aardvark stated that it will provide further updates on both ARD-101 and ARD-201 in the second quarter as it continues its evaluation and regulatory discussions.
Aardvark Halts ARD-201 Clinical Progress
Aardvark Therapeutics has announced a pause in its ARD-201 clinical trials after conducting a cardiac safety review of its related candidate, ARD-101. This decision reflects Aardvark’s commitment to prioritizing patient safety while carefully evaluating potential risks associated with its drug development programs.
Aardvark Reviews Cardiac Safety Signals
The pause comes after Aardvark identified cardiac-related safety observations during the evaluation of ARD-101. While details remain limited, Aardvark emphasized that the move is precautionary and part of standard clinical safety monitoring procedures. Ensuring patient well-being remains central to Aardvark’s development strategy.
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