HQ Team
January 30, 2025: Eli Lilly has stopped trials of its investigational drug to treat chronic kidney disease for a “lack of foreseeable clinical benefit,” according to a company statement.
The move to end trials during mid-stage comes after volenrelaxin failed a related heart failure study in an overlapping patient population.
The “study was terminated due to a lack of foreseeable clinical benefit in the proposed chronic kidney disease population, following the termination of a related heart failure study that demonstrated no benefit in an overlapping patient group,” according to the clinicaltrials.gov statement.
The company did not give details of the cardiovascular failure. It mentions that another Phase II trial, conducted in 137 locations, for chronic heart failure with preserved ejection fraction remains tagged as active but is not recruiting.
Recombinant relaxin protein
Volenrelaxin is a half-life-extended recombinant human relaxin protein developed for improving kidney perfusion and cardiorenal function.
Studies on animals of the synthetic molecule showed that it can elicit relaxin-related pharmacological responses, including greater renal blood flow in rats.
An early-stage study, which received funding from Eli Lilly, assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of volenrelaxin following single- and multiple-ascending doses administration.
“Volenrelaxin was well-tolerated, safe and suitable for weekly subcutaneous dosing. Volenrelaxin showed a sustained improvement in kidney perfusion upon repeated dosing, supporting further clinical development in chronic kidney disease and chronic heart failure,” according to the authors.
Loss of kidney function
Chronic kidney disease (CKD) affects about 37 million adults in the US and is expected to rise with an ageing demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure.
CKD is a condition characterised by a gradual loss of kidney function over time. Diabetes and high blood pressure are the most common causes of kidney disease.
Treatments include high blood pressure medications such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers to preserve kidney function, medications to relieve swelling etc.
CKD is a common complication of type 2 diabetes, with about 40% of people with type 2 diabetes also experiencing CKD. For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death.
Boehringer Ingelheim, AstraZeneca
Boston Medical Center (BMC) is the leading patent filer in kidney disorder treatment compositions. The research focuses on the immunopathogenesis of glomerular diseases, structural biology of the glomerulus, mechanisms of autoimmunity, renal cystic disease and cancer, kidney development and mechanisms of cell injury in acute renal failure.
Idexx Laboratories is the top company, followed by Proteomics International Laboratories and St Vincent’s Health Australia in application diversity.
Using geographic reach, Biogen holds the top position, while Proteomics International Laboratories and Sanofi are second and third, according to GlobalData.
Other global companies developing new drugs for CKD include Boehringer Ingelheim, AstraZeneca, and Astellas Pharma.
