Pharming announces enrolment of first patient in multicentre Phase IIb clinical trial of RUCONEST for the prevention of acute kidney injury after myocardial infarction
- Clinical trial follows encouraging results from a Phase II, which showed a statistically significant improvement of kidney injury biomarkers in patients undergoing coronary angiography after treatment with RUCONEST
- First patient has been enrolled at the University Hospital Basel, Switzerland, with additional clinical centres in Switzerland to join the study
LEIDEN, The Netherlands, April 22, 2021 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announces that the first patient has been enrolled in a Phase IIb double-blind, randomized, controlled study to assess the efficacy of RUCONEST (recombinant human C1 esterase inhibitor, or "rhC1INH") for the prevention of acute kidney injury after non-ST elevation myocardial infarction at the University Hospital Basel, Switzerland.
In October 2018, Pharming Group N.V. announced positive results from a Phase II investigator-initiated, double-blind, placebo-controlled clinical trial of RUCONEST in patients at risk of nephropathy following coronary angiography. The positive results were especially clear in the sub-group of patients undergoing percutaneous coronary interventions such as stent insertions. The intent-to-treat analysis in this group showed that patients on RUCONEST had a median percentage change in peak urinary neutrophil gelatinase-associated lipocalin within 48 hours, the primary endpoint for the study and a generally-recognized early marker of acute renal injury, of 11.3% in the RUCONEST arm and 205.2% in the placebo arm (p=0.001). The overall assessment of the study also showed trends that patients undergoing more invasive interventions and procedures requiring higher volumes of contrast medium experienced a stronger benefit from treatment with RUCONEST.
Following these encouraging results, the Company, in partnership with treating physician Dr Michael Osthoff from the University Hospital of Basel, Switzerland, saw potential for a larger, randomized, controlled multicenter study to investigate the full extent of the role of RUCONEST in the prevention of acute kidney damage after percutaneous coronary intervention for myocardial infarction. If successful, the clinical trial could also support further development of RUCONEST to prevent AKI from a wide variety of causes.