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Evotec Completes First Phase-I Study With EVT 401

PBR Staff Writer Published 29 June 2009

EVT 401, a small molecule drug candidate to orally treat inflammatory conditions

Evotec has completed first phase-I study with P2X7 receptor antagonist, EVT 401. EVT 401 is a small molecule drug candidate and a potentially novel approach to orally treat inflammatory conditions, such as Rheumatoid Arthritis.

The study was a double-blind, placebo controlled study investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of EVT 401. A total of 96 healthy male volunteers received single oral ascending doses of the compound, as a suspension or capsule. The study demonstrated that the compound was safe and well tolerated and there were no serious adverse events or withdrawals.

In addition, the pharmacodynamic assay used in the study demonstrated the ability of EVT 401 to block ATP-stimulated IL-1ß release in whole blood samples taken from volunteers, thereby proving on target activity at well tolerated oral doses.

Dr. Werner Lanthaler, CEO of Evotec, said: We are encouraged that EVT 401 showed positive results in its first human trial. It was well tolerated and demonstrated the desired pharmacodynamic activity in healthy volunteers. We are now focussing our efforts on optimizing the oral dose formulation, completing the Phase I studies, and preparing Phase II studies in Rheumatoid Arthritis.

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