NOXXON's Emapticap Pegol Study Selected for Late Breaking Clinical Trials Symposium during ERA-EDTA Conference

Full clinical data presentation for anti-CCL2 /MCP-1 Spiegelmer® emapticap pegol (NOX-E36)

(PresseBox) ( Berlin, Germany, )
NOXXON Pharma AG announced that Prof. Hermann Haller, Director of the Department of Nephrology and Hypertension at Hannover Medical School, was invited in his role as the principal investigator to present the full data of NOXXON's phase IIa clinical trial with emapticap pegol (NOX-E36), for the treatment of diabetic nephropathy during the 2014 congress of the European Renal Association and the European Dialysis and Transplant Association.

The talk entitled "CCL2 inhibition with emapticap pegol (NOX‐E36) in type 2 diabetic patients with albuminuria" was given during the first symposium of late breaking clinical trials on Sunday, June 1st. The ERA-EDTA congress is Europe's premier nephrology conference, including physiology, clinical nephrology, dialysis and transplantation.

Emapticap pegol (NOX-E36) is a Spiegelmer® that binds and inhibits the chemokine CCL2 (MCP-1). Based on pre-clinical work it is believed that the neutralization of this chemokine will prevent infiltration of pro-inflammatory cells into the kidney, thereby allowing existing inflammation to resolve over time. The expected downstream effects include preservation of podocyte numbers, as well as conservation of renal structure and function. The objective of the study was to determine the renoprotective and antidiabetic potential of emapticap pegol in type 2 diabetic patients with albuminuria.

The exploratory trial was laid out as a randomized, double blind, placebo-controlled phase IIa study and enrolled 75 albuminuric type 2 diabetics on a stable standard of care regimen which mandatorily included RAS* blockade. Emapticap was administered subcutaneously at 0.5 mg/kg twice weekly for 12 weeks, followed by a treatment-free observation phase of 12 weeks.

In the Full Analysis Set/ Intent to Treat (ITT) population, strong trends were seen for reduction of protein in the urine as measured by the albumin to creatinine ratio (ACR), as well as for glycated hemoglobin (HbA1c) in blood. These reductions became statistically significant in a subgroup of 49 patients believed by NOXXON to be most relevant for future studies in this indication (see table below). This was defined as the Primary Efficacy Analysis Set (PEAS). The PEAS dataset excludes those patients with major protocol violations, those treated with dual RAS* blockade which is now widely considered contraindicated, and those presenting with concomitant hematuria and leukocyturia suggestive of a kidney pathology different from diabetic nephropathy. Emapticap pegol was generally safe and well tolerated in this study.

Importantly, the effect on ACR was not accompanied by relevant hemodynamic changes which is consistent with a novel mechanism of action and differentiates emapticap pegol from approved drugs.

Prof. Haller concludes: "The inhibition of the CCL2:CCR2 axis with emapticap pegol is well tolerated and reduces ACR and HbA1c in type 2 diabetics with albuminuria. The maintenance of the effects even after cessation of treatment suggests that CCL2 blockade interferes with the underlying pathophysiology. Emapticap pegol may hence be the first disease-modifying drug for this indication."

* Renin Angiotensin System
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