Phase III data shows the potential of Bayer’s Kerendia to reduce the risk of all-cause and cardiovascular mortality in type 2 diabetes patients with chronic kidney disease.
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On Monday, Bayer revealed data from a Phase III trial of Kerendia (finerenone), showing the drug’s potential to reduce the risk of all-cause and cardiovascular mortality in type 2
The FIDELITY trial is a combination of two other randomized, double-blinded and placebo-controlled studies: the 5,700-patient FIDELIO-DKD and the 7,300-patient FIGARO-DKD. With over 13,000 T2D patients enrolled in total, it is the largest Phase III cardiorenal outcomes program on record. Bayer was assessing the safety and efficiacy of Kerendia in cutting the risk of CKD progression and cardiovascular events in a diverse set of patients.
Late-breaking data from the overall FIDELITY population, presented at the European Society of Cardiology Congress 2022 (ESC), demonstrated that patients who received Kerendia had an all-cause mortality incidence rate of 8.5% versus 9.5% for their placebo counterparts. This yielded a hazard ratio estimate of 0.89, which narrowly missed the threshold for statistical significance (p=0.051).
However, in a prespecified on-treatment analysis, Kerendia reduced the likelihood of all-cause mortality and cardiovascular mortality by 18% each, both of which were statistically significant effects (p=0.014 and p=0.04, respectively). The drug also significantly cut cardiac death risk by 25% relative to placebo.
Kerendia also performed well regardless of baseline kidney function, though its relative advantage over placebo was more pronounced in patients with healthier kidneys.
“Building on the growing body of clinical evidence for finerenone, which demonstrated the benefit of this treatment on renal and cardiovascular outcomes, these new data highlight the positive effects of finerenone on morbidity and mortality across a broad range of disease severities in patients with chronic kidney disease and type 2 diabetes,” Gerasimos Filippatos, M.D., professor of cardiology at the National and Kapodistrian University of Athens, Greece and co-principal author of both the FIDELIO-DKD and FIGARO-DKD studies, said in a statement.
Kerendia is a non-steroidal and selective antagonist of the mineralocorticoid receptor, the overactivation of which is known to cause cardiac damage and aggravate CKD progression. The drug was approved by the FDA in July 2021 as a once-a-day tablet treatment for CKD associated with T2D. In February, the European Commission also gave Kerendia its regulatory nod, followed by Japan’s Ministry of Health, Labor and Welfare in March and the Chinese National Medical Products Association in June.
CKD is a very common and potentially deadly complication associated with diabetes, eventually occurring in up to 40% of T2D patients. Often, kidney damage worsens gradually and silently, with symptoms appearing only when the disease has progressed to an advanced stage.
T2D patients with CKD are typically treated with SGLT2 inhibitors. One of these is Eli Lilly’s Jardiance (empagliflozin), which earned $461 million in the second quarter of 2022 for the Indiana-based company, up 29% from the same period the year before. Another heavy-hitter in this therapeutic space is AstraZeneca, whose Farxiga (dapagliflozin) earned the company $1 billion in the second quarter of this year alone.
Farxiga was also featured in this year’s ESC, where findings from the Phase III DELIVER trial showed the drug led to a 3.1% absolute reduction in the risk of cardiovascular death or worsening of heart failure relative to placebo.
