Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.
Late last month, Aardvark Therapeutics voluntarily suspended the development of its lead compound after detecting “cardiac observations.” Now, these safety signals have pushed the biotech to also put on hold two mid-stage studies of its obesity asset.
Specifically, Aardvark will pause the Phase 2 POWER trial, which is looking at how well its obesity drug ARD-201 can keep the weight off in patients who have successfully lost 15% of their bodyweight on GLP-1 therapies, according to the company’s news release on Monday. The biotech is also suspending the Phase 2 STRENGTH study, which is combining ARD-201 with an unspecified GLP-1 drug and assessing its additive effects.
Aardvark did not say when it expects to resume these two mid-stage trials, only noting that it will provide “further guidance on the program” in the second quarter.
“We acknowledge the risks associated with Aardvark’s current programs,” analysts at William Blair told investors in a Tuesday morning note, referring not only to obesity but also to the recently suspended trial of ARD-101 in Prader-Willi syndrome, a rare genetic disorder that manifests as uncontrollable and insatiable hunger.
Still, the firm considers Aardvark to be “an intriguing investment opportunity” given its current trading value. The biotech was trading at $4 per share before the opening bell on Tuesday, down more than 69% year-to-date.
ARD-201 is based on ARD-101, which targets taste receptors in the intestine that, when activated, facilitate the secretion of local signaling molecules such as GLP-1, in turn suppressing hunger and boosting satiety. ARD-201 combines ARD-101 with a dipeptidyl peptidase-4 inhibitor, which helps prolong the activity of gut hormones, including GLP-1.
In late February, Aardvark announced it had detected heart signals in patients who had received ARD-101 “at above therapeutic doses” in a healthy volunteer study. While the biotech at the time described these events as “reversible,” it nevertheless elected to suspend enrollment and dosing in the Phase 3 HERO study “out of an abundance of caution.”
On Monday, Aardvark provided more details behind these cardiac signals. Two patients showed echocardiographic anomalies that could be indicative of reduced heart efficiency. These patients were on 1,600-mg doses of ARD-101 twice-daily with no prior dose escalation—twice the target dose in HERO.
The healthy volunteer study, the biotech noted, was being run as a “routine additional cardiac safety study” to fulfill requirements for a planned approval application for ARD-101.
Aardvark continues to assess these safety findings and is working with the FDA to determine the best path forward for ARD-101. As in the case of its obesity hold, the company will provide updates in the second quarter.
