Evolva successfully discussed clinical development plans for EV-077 in diabetes patients with German regulatory authority

20. Dec 2012

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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About Evolva

Evolva’s mission is to discover and provide innovative, sustainable ingredients for health, nutrition and wellness. Evolva uses biosynthetic and evolutionary technologies to create and optimise small molecule compounds and their production routes. For more information see www.evolva.com.

Contact Details
Evolva

Neil Goldsmith
CEO
[email protected]
+ 41 61 485 2005
Jakob Dynnes Hansen
CFO
[email protected]
+ 41 61 485 2034
Paul Verbraeken
IR
[email protected]
+ 41 61 485 2035

This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

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