BioAge’s NLRP3 inhibitor has shown potential to reduce high-sensitivity C-reactive protein (hsCRP), a key marker of cardiovascular risk, in an ongoing Phase I trial.
In the multiple ascending dose (MAD) Phase I trial, patients with obesity and elevated baseline inflammation who were treated with BGE-102 achieved an 83% median reduction in hsCRP after seven days, which increased to 86% at day 14.
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Additionally, 93% of patients achieved hsCRP <2 mg/L after two weeks, the clinically recognised threshold for reduced cardiovascular risk.
hsCRP is a blood biomarker that is widely used to measure low levels of inflammation in the body and assess a person’s risk for heart attack, stroke, and other cardiovascular diseases.
On top of a reduction in hsCRP, patients treated with BGE-102 achieved a 44% median reduction in serum IL-6 after 14 days. IL-6 is a key upstream driver of hsCRP production and a validated marker of cardiovascular risk. There was also a 30% reduction in fibrinogen and 93% suppression of IL-1β, also key markers of cardiovascular risk.
This data builds on interim data from December 2025, which showed the drug was well tolerated, with dose-proportional pharmacokinetics (PK) supporting once-daily dosing.
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By GlobalDataDr Kristen Fortney, CEO and co-founder of BioAge, said: “Chronic inflammation is now recognised as a major driver of cardiovascular disease—on par with cholesterol—yet it remains far less commonly treated.”
Fortney added that the findings support BioAge’s plans to advance BGE-102 into a Phase IIa study in H1 2026.
Fortney has previously touted the potential of BGE-102 as a combination therapy with glucagon-like peptide-1 receptor agonists (GLP-1RAs), which are at the forefront of obesity treatment.
Two pharma giants dominate the obesity market – Eli Lilly and Novo Nordisk. Both companies have subcutaneous GLP-1RAs for obesity on the market and are also poised to lead the oral segment. Novo Nordisk has moved ahead of Lilly with its oral formulation of Wegovy gaining approval from the US Food and Drug Administration (FDA) in December 2025.
Lilly is aiming for FDA approval of its oral drug orforglipron in 2026, following a submission before the end of 2025. The company is also seeking approval for the oral therapy in type 2 diabetes.
As per GlobalData’s The State of the Biopharmaceutical Industry 2026, key opinion leaders predict that obesity medications will remain a key focus in 2026 across the pharmaceutical sector.
GlobalData is the parent company of Clinical Trials Arena.
