Evotec Starts Phase I with EVT 103, an NR2B-selective NMDA Receptor Antagonist
News Sep 09, 2009
Evotec AG has announced the Phase I clinical study initiation for EVT 103, a small molecule NR2B-selective NMDA receptor antagonist. EVT 103 is a next generation molecule following EVT 101, the orally available compound currently planned to enter clinical development for treatment-resistant depression in collaboration with Roche.
The first-in-human Phase I study is a double-blind, placebo-controlled, randomized ascending dose study in healthy young male subjects. The endpoints of the study are safety, tolerability, pharmacokinetic profile and pharmacodynamic effects after oral single and multiple dose administration. In addition food interaction will be investigated.
The non-selective NMDA receptor blocker ketamine and another compound, an NR2B-selective NMDA antagonist, have been proven to provide substantial clinical benefit for patients with treatment-resistant depression. However, both molecules, for which proof of concept has been shown before, require parenteral administration, hence an orally active therapeutic option is needed.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "The development of EVT 103 is part of the alliance between Evotec and Roche to develop therapeutic options for patients with treatment-resistant depression, an area of high unmet medical need. EVT 103 is a compound which belongs to the next generation of molecules, is expected to show even better tolerability compared to EVT 101, thus reducing the risk for a successful programme development of an orally available selective NMDA antagonist, and a potential application in also other areas of high unmet medical need."
The Alzheimer drug candidate PRI-002 has successfully completed Phase I of clinical research involving healthy volunteers. When administered daily over a period of four weeks, the active substance proved to be safe for use in humans. The next milestone will be the proof of efficacy in patients in clinical Phase II.READ MORE