Bayer claims another win on its CKD and diabetes hopeful, though the question remains over just how big it is

Max Gelman
Associate Editor
After earning priority review for a top CKD and diabetes program back in January, Bayer is revealing more data that it hopes will boost its pitch to regulators.

Bayer’s finerenone has passed another Phase III test, the pharma announced Monday, saying the candidate met the primary endpoint in a second study evaluating treatment for CKD and type 2 diabetes. The difference here is this study included more patients with earlier stages of the disease than the first trial.

In the new study, finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or non-fatal CV events, such as heart attack, stroke or hospitalization for heart failure, Bayer said. Though the study was randomized and double-blinded, enrolling roughly 7,400 patients, Bayer did not release any p-values Monday.

“We have reached a significant milestone for finerenone by completing the largest Phase III clinical trial program to date focusing on chronic kidney disease and type 2 diabetes across a broad range of disease severity,” Christian Rommel, member of Bayer’s executive R&D committee, said in a statement.

Once Bayer releases the full results, the trial will join a package that includes data from an October paper showing finerenone statistically significantly delayed CKD, for both the disease itself and CKD related to type 2 diabetes. The experimental drug cut the risk of renal death by 18% over four weeks, amounting to a pristine p-value of p=0.0014.

The German pharma also succeeded on an important secondary in that trial, which happened to be the primary endpoint of Monday’s study. Despite coming closer to missing than the primary, finerenone reduced the risk by 14% in time to cardiovascular death, amounting to a p-value of p=0.03391.

Their first study enrolled about 5,700 patients. In total, Bayer has now tested finerenone in over 14,000 CKD patients over the course of these two trials.

Finerenone is a non-steroidal mineralocorticoid receptor inhibitor, looking to tamp down on what researchers found is a trigger for both inflammation and fibrosis. Bayer theorized finerenone could provide more benefit in stopping fibrosis while limiting inflammation in the heart and kidneys.

Bayer is pinning a lot of hopes on the program following some up-and-down years in R&D. Back in November 2018, the pharma slashed 900 R&D jobs as part of a restructuring process after its buyout of Monsanto. But it’s more recently begun a push into cell and gene therapies, acquiring AskBio for $4 billion in October and consolidating all such projects under one umbrella platform in December.

The candidate will still likely see an uphill battle should it hit the market after its PDUFA review period, as there are quite a few CKD drugs already on the shelves. An October analysis from Evaluate Pharma also drew concerns over whether Bayer would only be adding a marginal benefit on top of these drugs despite investing significant resources.