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Pharma Tech Outlook | Wednesday, April 28, 2021
Patients on RUCONEST had a median percentage improvement in peak urinary neutrophil gelatinase-associated lipocalin within 48 hours, the study's primary endpoint and a widely accepted early predictor of acute renal injury, of 11.3 percent in the RUCONEST arm and 205.2 percent in the placebo arm (p=0.001).
FREMONT, CA: Pharming Group N.V., a global, commercial-stage biopharmaceutical company, announced that the first patient has been enrolled in a Phase IIb double-blind, randomized, controlled study to evaluate the efficacy of RUCONEST (recombinant human C1 esterase inhibitor, or rhC1INH) for the prevention of acute kidney injury following non-ST elevation myocardial infarction at the University Hospital Basel, Switzerland.
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Prof. Bruno Giannetti, Chief Medical Officer, Pharming Group N.V., commented: "We are excited to initiate this important study with RUCONEST and look forward to a swift recruitment rate. The design of this clinical trial allows us to assess important NGAL levels, as well as a large number of clinical and laboratory parameters, which will provide valuable information in, not only, the assessment of acute kidney injury in the setting of myocardial infarction, but eventually across even broader etiologies. If found to be efficacious, RUCONEST could make a significant contribution to improving the life expectancy and quality of life of patients suffering from kidney damage."
Pharming Group N.V. reported positive results from a Phase II investigator-led, double-blind, placebo-controlled clinical trial of RUCONEST in patients at risk of nephropathy after coronary angiography in October 2018. The positive results were particularly noticeable in the subgroup of patients who had percutaneous coronary operations, such as stent implantations.
Patients on RUCONEST had a median percentage improvement in peak urinary neutrophil gelatinase-associated lipocalin within 48 hours, the study's primary endpoint and a widely accepted early predictor of acute renal injury, of 11.3 percent in the RUCONEST arm and 205.2 percent in the placebo arm (p=0.001). According to the report's overall findings, patients undergoing more invasive surgeries and procedures involving higher volumes of contrast medium benefited more from care with RUCONEST.
Following these promising findings, the company, in collaboration with treating physician Dr. Michael Osthoff of the University Hospital of Basel in Switzerland, saw the need for a broader, randomized, monitored multicenter study to determine the full extent of RUCONEST's function in the prevention of acute kidney damage following percutaneous coronary intervention for myocardial infarction. If the clinical trial is successful, it could pave the way for further production of RUCONEST to prevent AKI from various causes.
About the Study
Up to 220 patients will be enrolled in a double-blind, randomized, controlled trial to see whether RUCONEST will avoid acute kidney injury after a non-ST elevation myocardial infarction (NSTEMI). The primary endpoint is to equate the efficacy of rhC1INH to placebo after PCI in NSTEMI patients by looking at the peak rise in urinary NGAL (Urinary neutrophil gelatinase-associated lipocalin) within 24 hours of care.Besides, the research will look for an optimal dosing procedure for future research. The occurrence of AKI, characterized as an increase in serum creatinine within 72 hours after angiography, as well as cardiovascular and renal events and hospitalization-related medical resource use for six months, are also included in the study's endpoints. The research will be carried out in several locations around Switzerland.
About Acute Kidney Injury
Acute Kidney Injury (AKI) affects about 20 percent of all patients admitted to the hospital. The rapid onset of renal damage and dysfunction characterizes this condition. It is a serious complication that can affect patients' short- and long-term outcomes. In chronically ill patients or in the presence of risk factors such as chronic kidney disease, diabetes mellitus, and nephrotoxic drugs, the incidence will rise to more than 50 percent. Multiple mechanisms, including nephrotoxicity of the contrast agent and ischemia-reperfusion injury following PCI, may trigger AKI in the setting of myocardial infarction.
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