Noxxon presents positive results from emapticap pegol Phase IIa diabetic nephropathy study

Emapticap pegol is a Spiegelmer that binds and neutralizes CCL2/MCP-1 (C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1), a pro-inflammatory chemokine that plays an important role in diabetic kidney disease, the most common single cause of chronic kidney failure and end-stage renal disease.

The objective of this randomized, double-blind placebo-controlled multi-center international study was to evaluate the efficacy, pharmacokinetics, safety and tolerability of treatment with emapticap pegol.

A total of 75 type 2 diabetic patients with albuminuria on current standard of care to control hypertension, hyperglycemia and dyslipidemia were treated for 12 weeks with twice-weekly subcutaneous emapticap pegol or placebo. This treatment period was followed by a 12 week observational period to study the long-term effect of emapticap pegol treatment on albuminuria.

Importantly, the underlying standard of care mandatorily included stable renin-angiotensin system (RAS) blockade, which has been demonstrated to reduce albuminuria and to slow progression of diabetic nephropathy.

Emapticap pegol was found to be safe and well tolerated with no treatment-related serious adverse events. For the primary efficacy analysis, patients with major protocol violations, on dual RAS blockade, or with concomitant hematuria and leukocyturia were excluded.

Results showed relevant, statistically significant reductions in urinary albumin excretion and improved glycemic control. Importantly, these effects were independent of hemodynamic changes and maintained after cessation of treatment, suggesting that emapticap pegol interferes with the underlying pathophysiology of diabetic nephropathy.

Long-lasting effects on urinary albumin after cessation of treatment are not seen with agents currently approved to treat diabetic nephropathy (ACE inhibitors and ARBs1) or with other agents that act primarily via a hemodynamic mechanism of action such as endothelin A receptor antagonists.

Dr Hermann Haller, director of the Department of Nephrology and Hypertension at Hannover Medical School and lead investigator of the study noted that this Phase IIa study clearly shows that emapticap pegol is exceptionally safe and well tolerated in the target population and produces significant and clinically relevant beneficial effects on albuminuria and glycemic control after only three months of treatment.

"The observation that these effects are maintained even after cessation of treatment suggests that emapticap pegol interferes with the underlying pathophysiology and may be the first disease-modifying drug for this indication," Dr Haller added.