Evolva’s EV-077 achieved objectives in first group of patients in Phase IIa trial
Further data to be presented at ESC Congress 2012
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.
Evolva will present further data in a parallel symposium titled “EV-077: a novel approach to vascular inflammation” at the European Society of Cardiology (ESC) Congress 2012 on 28 August 2012, in Munich, Germany. Link: http://spo.escardio.org/SessionDetails.aspx?id=399515. The information presented at the symposium will be made available via Evolva’s website on 29 August, at the same time as Evolva’s half year results.
Neil Goldsmith, CEO of Evolva, commented
“The early efficacy data are encouraging and seem to underpin the potential of EV-077. We are in contact with BfArM regarding next steps. We are looking forward to sharing our data with the scientific and medical community at the ESC Congress 2012.”
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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. We are active in consumer healthcare and nutrition as well as in pharma. In both areas we have partnered projects as well as proprietary programmes. For more information see www.evolva.com.
About the Phase IIa study
The study is designed to assess to safety, tolerability and pharmacokinetics of 28 days EV-077 treatment, and its effects on platelet function, vascular inflammation and oxidative stress in type II diabetics. It is a single-centre study, conducted in Germany. The intention is to enrol up to 64 evaluable patients. The study is randomised, double-blind and placebo-controlled. Measurements include oxidative stress, vascular inflammation, blood flow and platelet reactivity, as well as markers of the function of organs that are often impaired in diabetes (e.g. kidney, retina).
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|Jakob Dynnes Hansen
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