Novo Nordisk’s IL-6 inhibitor ziltivekimab failed to lower the risk of cardiovascular complications in the Phase 3 ZEUS trial, according to an announcement on Aug. 3. The outcome has had a significant effect on other companies in the inflammatory disease sector.
BioAge Labs and Monte Rosa Therapeutics experienced notable stock declines following the news. By Friday’s close, BioAge shares fell by 63.6% to $9.04 per share, while Monte Rosa dropped 27% to $16.52. Other companies were also affected: Neurocrine Biosciences’ stock decreased by 10% to $166.8, and Neumora slid by 2.4% to $1.61.
BioAge is developing BGE-102, an orally available drug aimed at lowering cardiovascular risk by reducing high-sensitivity C-reactive protein (hs-CRP), a biomarker of inflammation. Analysts at William Blair said that BioAge was heavily impacted due to “negative readthrough from the ZEUS trial that challenges the correlation between significant hsCRP reduction and MACE [major adverse cardiovascular events] protection.”
In April, BioAge released Phase 1 data showing BGE-102 reduced hs-CRP by 85% at day seven for its highest dose level; CEO Kristen Fortney said these findings position BGE-102 as a potential “single oral therapy to address NLRP3-driven inflammation in cardiovascular, ocular, and CNS diseases.” However, William Blair said that ZEUS now “challenges” this assertion because ziltivekimab also lowered hs-CRP levels but did not result in improved cardiovascular outcomes.
Monte Rosa is advancing MRT-8102 for IL-1β/NLRP3-driven inflammation with interim Phase 1 data showing an 85% reduction in hs-CRP after four weeks among patients with elevated cardiovascular disease risk; CEO Markus Warmuth previously said this could “establish the significant potential opportunity for MRT-8102 in multiple chronic inflammatory diseases.”
William Blair added that impacts on Neumora and Neurocrine are more limited, since their pipelines do not heavily rely on inflammation-targeting programs.
