Evolva Holding SA (SIX: EVE), announced it has initiated a multiple ascending dose Phase I clinical study with an extended release oral formulation of EV-077.
An earlier first-in-man single ascending dose study with an oral solution of EV-077 indicated that it was a potent, fast-acting and reversible inhibitor of platelet aggregation. Subsequent formulation development work to optimise the pharmacokinetic profile has led to four different extended release oral formulations being evaluated in a four-way crossover study involving 12 healthy volunteers and conducted in Germany. The study demonstrated that all formulations were well tolerated, and identified a lead candidate that could optimise exposure.
The selected extended release formulation will be evaluated in a multiple ascending dose study to be conducted in Germany, and for which ethical and regulatory approval has been received. The aim of the study is to determine the optimal dose range for Phase II.The study will involve 32 volunteers and is expected to complete in the first half of 2011.
Dr. Alexandra Santana Sorensen, responsible for compound development said: “We are very pleased with the progress made in the development of an extended release formulation of EV-077, which will now allows us to establish the pharmacodynamic and safety profiles of repeat administration of increasing doses, and which takes us a step closer to establishing proof-of-concept in a patient population.”
EV-077 (full name EV-077-3201-2TBS) is a new chemical entity, with a different mode of action from existing drugs that is being developed for renal and cardiovascular indications, in particular proteinuric kidney diseases and anti-platelet indications.
Source: Evolva Holding SA