Bayer HealthCare has announced that the clinical trial program for the investigation of their heart failure drug named Finerenone will be expanding with its final stage (Phase III) trials. In the said stage of the investigations, the scientists will look into the effectivity and safety of the drug in patients diagnosed with chronic heart failure and diabetic kidney disease. The participants for this phase are said to be enrolled during the latter part of 2015.
The pharmaceutical company's Xarelto and Eylea, which are stroke prevention and eye treatment drugs respectively, have gained approval and positive feedbacks recently; thus, the German firm continues to strike while the iron is hot. With the advancements of Finerenone, the company hopes to step up in the cardiovascular treatment aspect as the Phase II trials exhibited significant decline in mortalities.
Finerenone is a mineralocorticoid receptor antagonists (MRA), which is effective in treating salt-related hypertension. Other MRAs that are currently available in the market such as eplerenone and spironolactone (Inspra) manufactured by Pfizer are said to be incompatible with majority of patients because these can lead to significant elevation of blood potassium levels, which may subsequently result in irregular heart beat and ultimately, cardiac arrest. These old drugs are also said to be associated with kidney conditions. However, Finerenone has a different mechanism of action that is said to counter these issues. With this, cardiac specialists are eagerly looking forward to its progress.
The findings of the Phase II clinical trials, which was presented on Monday, Aug. 31, in London, showed that patients who were administered with Finerenone exhibited lesser deaths and hospitalizations during the 90-day initial treatment period, compared to those in the control group, who were administered with eplerenone. The company did not expect to see clear improved results at just the Phase II, says Frank Misselwitz, head of the therapeutic area cardiovascular and coagulation at Bayer.
In the upcoming Phase III trial, Bayer plans to enroll about 3,600 participants diagnosed with both heart failure, diabetes and/or kidney disease.
"We are excited about finerenone being the first MRA that is being developed in parallel in chronic heart failure and diabetic kidney disease," says Joerg Moeller, head of Global Development and member of the Bayer HealthCare Executive Committee. The research will analyze if the drug can decrease the cardiovascular morbidities and mortalities, and the development of kidney disease in the same participants.
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