Evolva’s EV-077 achieved objectives in first group of patients in Phase IIa trial

20-Aug-2012 - Switzerland

Evolva Holding SA announced top-line results for the first 32 patients enrolled in the Phase IIa study of its investigational drug, EV-077, a novel, reversible antagonist of isoprostanes and prostanoids.

The initial  analysis shows promising efficacy data, indicating that 300mg EV-077 given orally twice daily to patients with type 2 diabetes provided anti-platelet activity, reduced exercise-induced proteinuria and increased forearm blood flow. This was achieved with only a slight increase in bleeding time. The analysis also indicated that EV-077 was generally well tolerated, with adverse events mostly limited to increases in liver enzymes, which were transient or resolved after discontinuation.

Evaluation of the data of the first 32 patients of the Proof-of-Concept study was part of the adaptive design agreed with the German regulatory authority BfArM. Evolva is exploring, in consultation with BfArM, how to best address the liver enzyme elevations, for example by using lower doses in the second part of the study. The initial analysis supports the hypothesis that lower doses will demonstrate efficacy. 

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