Evotec completes first-in-human Phase I study of EVT 103 for treatment-resistant depression

Mar 11 2010

• Successful completion of first-in-man study with EVT 103
• Positive feedback from the FDA to initiate Phase II with EVT 101

Evotec AG (Frankfurt:EVT) (TecDAX) today announced two positive aspects that strengthen its integrated product development in treatment-resistant depression in its strategic alliance with Roche.

Evotec AG completed the clinical part of the first Phase I study with its NR2B-selective NMDA receptor antagonist EVT 103. EVT 103 is a small molecule drug candidate intended for oral use in conditions such as treatment-resistant depression, but potentially also other CNS indications.

The first-in-human Phase I study was a double-blind, placebo-controlled, randomised ascending dose study in 72 healthy young male subjects. The endpoints of the study were safety, tolerability and pharmacokinetic profile after oral single and multiple dose administration. In addition, the effect of food on the pharmacokinetics of EVT 103 was investigated. The compound was safe and very well tolerated, with excellent bioavailability and only a minimal effect of food on the kinetic profile.

In addition, for its NMDA receptor antagonist EVT 101, which is the lead compound in the strategic alliance with Roche in treatment-resistant depression, the FDA has allowed Evotec to proceed with the initiation of a Proof-of-Concept study. The study will start recruiting patients in Q2.

"We are glad that we received positive feedback from the FDA regarding the toxicology and safety aspects of the planned Proof-of-Concept study with EVT 101. In addition, the Phase I results of EVT 103 now make this a very strong programme for a clinical product development in treatment-resistant depression," said Dr. Werner Lanthaler, Chief Executive Officer of Evotec.