Reinach, Switzerland, 20 December 2012 – Evolva Holding SA (SIX: EVE) today announces it has had a positive meeting with the German regulatory authority BfArM regarding the further clinical steps for EV-077 (a novel, reversible antagonist of isoprostanes and prostanoids, in Phase IIa to treat vascular inflammation and complications of diabetes). Initial Phase IIa efficacy data have been published in August 2012.
Evolva has discussed the future clinical development programme of EV-077 with BfArM in a scientific advice (SA) meeting. The proposed clinical development programme in diabetic patients was perceived as a reasonable approach by BfArM and Evolva received valuable input on the design of future phase II studies from the BfArM experts. Based on the outcome of the SA meeting, the next step is to set up a study protocol and file the clinical trial application for a dose range finding study in diabetic patients, investigating lower doses of EV-077 than the one administered in the first group of patients in the Phase IIa study. As announced earlier, any further development of EV-077 will be pursued via means of partnering or a spin out of the programme.
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