A small San Diego biotech wants to take a different approach to the weight loss drug R&D field by going after hunger rather than suppressing appetite like the wildly popular GLP-1 class.
“Most folks will conceptualize appetite and hunger as, ‘Aren’t they just different extremes along the same continuum?’” Aardvark Therapeutics CEO Tien Lee told Endpoints News. “But they’re actually two different neurologic drives.”
Investors are backing the startup with an $85 million Series C, about $35 million more than its initial goal for the round, Lee said.
The proceeds will back late-stage studies of the biotech’s candidate, the bitter taste receptor agonist ARD-101, in patients with Prader-Willi syndrome, a rare genetic disease that can cause unrelenting feelings of hunger.
“If you swallow something bitter, it’s been known to also turn off hunger, and we wanted to explore whether engaging the bitter taste receptors outside the mouth could really curb eating behavior,” Lee said.
The goal is to file for approval and land an FDA nod in 2026, Lee said. The funding will also support Phase 2 testing of the oral small molecule in people who have withdrawn from GLP-1 medications.
Hunger, not appetite
With its gut-restricted candidate ARD-101, Aardvark hopes to tamp down on hunger. Its investigational drug activates secretion of GLP-1 but also cholecystokinin, or CCK, which also helps regulate eating behavior, Lee said.
ARD-101 is “very, very bitter but also very, very safe,” he added.
Novo Nordisk’s semaglutide medicines (Wegovy for chronic weight management and Ozempic for type 2 diabetes) and Eli Lilly’s tirzepatide drugs mimic the appetite suppressor GLP-1. Tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management, also targets GIP.
ARD-101 has been through a Phase 2 in Prader-Willi syndrome. The Series C will either fund an additional Phase 2 and then a Phase 3, or a single registrational trial in the indication, Lee said, as the company is still determining the clinical plans for the twice-daily drug.
Aardvark will also study whether ARD-101 can help patients who have withdrawn from GLP-1 medications, a common phenomenon as the class of drugs can lead to nausea and muscle loss, and patients have been found to regain weight after stopping treatment, among other issues.
Lee said the biotech expects to pair a once-daily version of ARD-101 with Januvia, a dipeptidyl peptidase-4 inhibitor indicated for type 2 diabetes, in a Phase 2 trial. Aardvark has “not fully determined if we will include only diabetes or pre-diabetes patients,” Lee said, as the planning is still in progress. In preclinical studies, the Merck-marketed Januvia “more than doubles the effect of our drug on its own,” Lee said.
The dozen-employee biotech is also in Phase 2 with ARD-501, an asset being studied in people with autism spectrum disorder. Its pipeline also includes an oral candidate for overactive bladder, a topical for inflammatory skin disorders and an abuse deterrent.
Debating an IPO
Prior to the Series C, Aardvark had disclosed a $29 million Series B in August 2021 and $15 million Series A in November 2019.
Decheng Capital led the Series C. Additional investors include Cormorant Asset Management, Surveyor Capital, SymBiosis and more than half a dozen other backers.
The biotech is contemplating whether an IPO is its next step, which the Financial Times reported could happen this summer. Other obesity drugmakers are also eyeing the public markets, including Eccogene and Kallyope, according to a January report from Bloomberg.
With the Series C, Aardvark will have time to make a decision: The cash is slated to carry the biotech beyond the NDA filing, so it has a few years of runway, Lee said.
“An IPO is on the table if the market conditions are reasonable, but we’re not necessarily having that as our only plan,” Lee said. “We are having meaningful conversations with more than one large pharma company that are exploring possibilities for licensing or partnership.”