The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.
By FRANK VINLUAN
Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease.
The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion.
The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney disease. Drugs are already available that block this receptor, including Bayer’s Kerendia, which won its FDA nod in 2021 for treating chronic kidney disease in patients with type 2 diabetes.
Novo Nordisk and KBP say some mineralocorticoid receptor antagonists increase the risk of hyperkalemia, in which elevated potassium levels in the blood can lead to muscle weakness, paralysis, cardiac arrhythmias, and sudden cardiac death. Hyperkalemia is a rare but known side effect risk of Kerendia. Singapore-based KBP describes its small molecule as a third-generation of mineralocorticoid receptor-blocking drugs, bringing a high affinity to that receptor as well as a long half-life. The company contends its once-daily oral drug has potential best-in-class safety and efficacy.
Uncontrolled hypertension is defined as a patient continuing to have high blood pressure despite two or more blood pressure-lowering treatments. In a Phase 2b study that enrolled patients with stage 3b/4 chronic kidney disease and uncontrolled hypertension, results showed the KBP drug met the main goal of showing a statistically significant reduction in blood pressure compared to baseline measures. Furthermore, no cases of severe hyperkalemia or acute kidney injury were reported.
The clinical trial results were published in 2021 in Hypertension, a journal of the American Heart Association. Last year, KBP began a global Phase 3 test of ocedurenone with a targeted enrollment of more than 600 patients who have uncontrolled hypertension and advanced chronic kidney disease. Novo Nordisk expects to start Phase 3 studies in additional cardiovascular and kidney disease indications in coming years to fully realize its new asset’s potential.
“Hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk said in a prepared statement. “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating uncontrolled hypertension and could help address a major unmet medical need in people living with cardiovascular disease and chronic kidney disease.”
Novo Nordisk expects to close its acquisition of KBP’s ocedurenone by the end of the year. It’s the latest in a string of deals the Danish pharma giant has made as it continues its strategy of diversifying beyond diabetes. Over the summer, Novo Nordisk reached deals to acquire Inversago Pharma and Embark Biotech, each offering a different approach to weight loss medications. Three weeks ago, Novo Nordisk paid $60 million up front to acquire three preclinical cardiovascular programs that Valo Health discovered with its artificial intelligence technology platform.