BioAge axes obesity asset over liver toxicity, pivots to preclinical prospects

BioAge Labs has given up on its lead obesity candidate. Weeks after stopping a trial in response to phase 2 data, the biotech has jettisoned the molecule and shifted its focus to a preclinical neuroinflammation prospect.

California-based BioAge raised around $200 million in an IPO in September and swiftly reminded public investors that biotechs are risky bets. Two months after going public, BioAge stopped a phase 2 trial of its oral apelin receptor agonist azelaprag. Investors fled, but the biotech left the door open, noting that it remained encouraged by preclinical and early-phase data and vowing to share updated plans in 2025.

BioAge closed the door on azelaprag Tuesday, explaining that the elevated liver enzymes seen in some patients without clear dose dependence had persuaded it to call time on the program. The biotech has structurally distinct molecules in its pipeline and aims to pick a follow-up candidate this year.

With the apelin program bouncing back to preclinical, BioAge’s NLRP3 inhibitor has become the biotech’s most advanced prospect. Management has picked brain-penetrant molecule BGE-102 as its development candidate and is running studies to support a filing to test the asset in humans. BioAge expects to post phase 1 single-ascending dose data on the candidate this year.

NLRP3 was a hot target as the 2010s drew to a close, when Bristol Myers Squibb, Novartis and Roche—both through its mothership and Genentech subsidiary—all acquired assets. None of the deals has led to an approved NLRP3 inhibitor.

BioAge is initially focused on molecules that are active in the central nervous system. NodThera, Ventyx Biosciences, Roche and Ventus Therapeutics have all worked on similar molecules, but BioAge is bullish, with CEO Kristen Fortney, Ph.D., using a Citi event last month to claim the candidates are “an order of magnitude more potent than the competition.”

The biotech’s focus on the neuroinflammatory uses of NLRP3 inhibition is built on longevity data linking the protein to accelerated cognitive aging and shorter life spans. BioAge also has evidence that inhibiting the protein could suppress appetite, suggesting there is scope to expand into obesity.

Investors appeared to have priced in the pivot away from azelaprag, with the stock opening flat Tuesday. BioAge’s stock has fallen more than 75% since last year’s IPO, but the biotech has the money to write a second act—the company's cash runway extends beyond 2029. BioAge disclosed a collaboration with Lilly ExploR&D to discover two antibodies against metabolic aging targets identified by the biotech.