Aardvark Therapeutics has confirmed it is walking away from recently terminated phase 3 trials, telling investors it has no plans to resume the studies “as previously designed” as the biotech works to find a path forward for its stalled pipeline.
The company announced the update along with confirmation that Aardvark had slimmed down its workforce in June. Having ended April with 40 employees and 35 consultants, the biotech had reduced its team to 28 employees and 27 consultants by the end of July.
The company sniffed out a threat to its lead candidate, ARD-101, earlier this year, when “reversible cardiac observations” in healthy volunteers prompted it to pause a phase 3 trial in Prader-Willi syndrome (PWS). Weeks later, the biotech extended the pause to ARD-201, a phase 2 prospect that combines ARD-101 with a DPP-4 inhibitor. In May, Aardvark said that the FDA had imposed a full clinical hold on all studies of ARD-101.
Management disclosed the FDA hold, along with details of plans to unblind results from the phase 3 PWS trial and its associated open-label extension study. The biotech terminated the studies on the federal trials database in June, citing operational and regulatory considerations.
Aardvark provided an update on the terminated studies after the stock market closed Tuesday, using its quarterly results to tell investors that the company “does not currently intend to resume these trials as previously designed.”
The wait continues for news on potential further development of the drug candidates. In May, Aardvark told investors to expect guidance on the futures of ARD-101 and ARD-201 in the second quarter. Yet the quarter came and went without news. In its latest update, Aardvark said it is assessing its unblinded data in the third quarter “to support an informed determination of next steps.”
William Blair analysts said in an August 12 note to investors that they expect Aardvark to provide “a more fulsome update—specifically, a path forward that is aligned with the FDA—later this year.” Preliminary signals from the unblinded phase 3 program “could better position Aardvark to design and conduct the second registration-enabling study,” the analysts said.
Aardvark forecasts its cash runway will reach into late 2027. Before its pipeline derailed, the company expected its funds to last into 2027, but the runway has extended amid slower spending.