Fresh from IPO, obesity drug developer BioAge hits a hurdle

Kristen Fortney, CEO and co-founder of BioAge Labs
It has only been a few weeks since BioAge made its Nasdaq debut via a $198 million IPO, and it has already suffered a setback with its main drug candidate.
The Richmond, California-based start-up has discontinued a phase 2 trial of its obesity drug azelaprag as a monotherapy and in combination with Eli Lilly’s blockbuster weight-loss therapy Zepbound (tirzepatide) after seeing signs of potential liver damage in patients.
Various subjects enrolled into the STRIDES trial showed elevations in liver transaminase enzymes – a sign of liver inflammation – “without clinically significant symptoms,” said BioAge in a statement. There were no increases in transaminases in a control group receiving tirzepatide alone.
“Patient safety is our top priority in the conduct of our clinical studies,” said Kristen Fortney, co-founder and chief executive of BioAge, in a statement.
“We made the difficult decision to discontinue the STRIDES phase 2 study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy,” she added. The study was due to generate results towards the end of 2025.
It’s a crushing disappointment for the newly listed biotech, which tapped into the massive appetite of investors for companies with obesity assets by upscaling its IPO from an initial target of $100 million.
Azelaprag, the company’s main clinical candidate, is an oral apelin receptor agonist designed to amplify the weight loss achieved with tirzepatide and other obesity drugs – including Novo Nordisk’s Wegovy (semaglutide) – and also improve the body composition of treated patients by preserving muscle mass.
Azelaprag was formerly owned by Amgen, which was looking at it as a potential therapy for heart failure, but discontinued the programme after disappointing trial results. BioAge licensed exclusive worldwide rights to it in 2021.
Fortney said that the setback does not spell the end of the programme, adding that BioAge remains “encouraged by azelaprag’s promising preclinical and Ph1b efficacy profile.”
The company will consider the fate of the drug – planning to give an update in the first quarter of 2025 – whilst simultaneously advancing an NLRP3 inhibitor with potential in neuroinflammation through development.
Shares in BioAge had lost nearly 71% of their value in pre-market trading at the time of writing and were trading at around $5.85, well short of its debut price of $18.31 and all-time-high of $26.62.