Evotec Announces the Successful Completion of the First Phase I Study with EVT 401
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Evotec AG has announced the successful completion of the first Phase I study with its 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 compound was very safe and well tolerated and there were no serious adverse events or withdrawals. In addition, the pharmacodynamic assay used in this study demonstrated the ability of EVT 401 to block ATP-stimulated IL-1ß release in whole blood samples taken from subjects, thereby proving “on target” activity at well tolerated oral doses.
In Rheumatoid Arthritis, the first potential indication for EVT 401, there is a significant need for new oral therapies. Oral drugs can be used both as alternatives to and in combination with existing agents to increase the responder rates and potentially reduce or delay the need for expensive bio-logical therapies.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: “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.”
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 compound was very safe and well tolerated and there were no serious adverse events or withdrawals. In addition, the pharmacodynamic assay used in this study demonstrated the ability of EVT 401 to block ATP-stimulated IL-1ß release in whole blood samples taken from subjects, thereby proving “on target” activity at well tolerated oral doses.
In Rheumatoid Arthritis, the first potential indication for EVT 401, there is a significant need for new oral therapies. Oral drugs can be used both as alternatives to and in combination with existing agents to increase the responder rates and potentially reduce or delay the need for expensive bio-logical therapies.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: “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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