Evotec starts Phase I with EVT 103, an NR2B-selective NMDA receptor antagonist


Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) announced today 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." 

About NMDA receptors

NMDA receptors are involved in the pathology of depression. NR2B-selective antagonists bind preferentially to the activated form of the NMDA receptor containing the NR2B subunit and allosterically modulate, in an activity-dependent manner, channel activity by inhibiting channel opening probability. They show advantages over non-selective NMDA antagonists due to greater separation of efficacy from side effects.

Terms of the Agreement with Roche

Evotec has entered an alliance with Roche with the potential value of this transaction exceeding USD 300 million. Evotec is responsible for conducting Phase II clinical development of EVT 101 in patients with treatment-resistant depression, a compound originally discovered by Roche and developed from discovery stages through clinical studies by Evotec. Within this alliance, Evotec will also conduct Phase I safety and tolerability studies for EVT 103, a next generation compound to EVT 101. Roche will fully fund these development programs.

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