Until last year, BioAge Labs' progress could be best described as a slow burn, with a pipeline of longevity-focused medicines taking shape incrementally but consistently.
The frenzy around GLP-1s changed all of that, with BioAge’s profile ascending dramatically thanks to being one of a select few biotechs with a combo candidate that might enhance weight loss without muscle loss. Equipped with that potential, and a partnership with Eli Lilly to test the hypothesis, BioAge has closed a $170 million series D led by Sofinnova with contributions from major institutional biotech investors and the venture arms of both the Indianapolis pharma and Amgen.
The financing is enough to last almost three years, at least, CEO Kristen Fortney, Ph.D., said in an interview with Fierce Biotech ahead of Tuesday’s announcement. Atop the to-do list is a phase 2 trial testing lead asset azelaprag with Lilly’s tirzepatide, marketed as Zepbound for weight loss. The primary endpoint of the trial will be weight loss, data Fortney is eager for based on preclinical data she believes should translate well. Fortney hopes that when combined with the low dose of tirzepatide, oral azelaprag can boost patients’ average weight loss reduction from 15% to 20%.
Body composition data will serve as key exploratory endpoints, which if BioAge can even hit just one, would be exciting, Forney added.
The size of the series D and the makeup of the investor group catapult BioAge to the forefront of the metabolic space and set it up to go public in the future. Although the series C was led by a16z (then Andreesen Horowitz), the investor base wasn’t built on a foundation of healthcare specialists. Now it is, with RA Capital, RTW and Longitude Capital all contributing to the series D, among others.
The cash pushes BioAge's cash runway into at least late 2026.
Fortney recognizes that for better or for worse (mainly for better), the internal pipeline is now laser-focused on treating weight loss and obesity, at least in the near term. This deviates a bit from BioAge’s original billing, which was a broader biotech tackling diseases intrinsically tied to aging. The company’s focus at the time of its $90 million series C was two assets for unexplained anemia in elderly patients and COVID-19 in patients without respiratory failure. Both of those assets are now gone from the pipeline, with the study testing COVID med BGE-175 terminated due to too few hospitalizations. BioAge acquired azelaprag from Amgen four months later, in April 2021.
Fortney said the company’s platform has broad applicability in age-related diseases and that BioAge’s focus on metabolic diseases likely tees up business development elsewhere.
“What it does mean is probably we're going to focus more on partnering for other areas as opposed to internal development,” she said. One of those assets is BGE-100, a NLRP3 inhibitor that BioAge believes could help treat neurodegenerative diseases due to neuroinflammation. Toxicology studies are ongoing, and the therapy could enter the clinic around the middle of this year.
The recent transformation of the company into one that has a more linear focus—at least for now—can be neatly packaged as part of a continuous learning experience for Fortney, who co-founded BioAge more than eight years ago. She has grown right alongside the biotech, recognizing that you can’t tackle every disease, and prioritizing is paramount. By doing so, she says she’s found the benefits of diving deeper into one disease area and how relevant targets, like the apelin receptor that’s the focus of azelaprag, may contribute to future therapies.
“That has been a shift over the past year … where I think there's actually a really great match to what our science can do, what our platform can do [and] what our people are excited about,” she said.
Editor's note: This story was updated after a spokesperson corrected the timeline for BGE-100. It could enter the clinic as soon as mid-2024, not mid-2025.