EVT 101 Phase II study started


Hamburg, Germany - 1 July 2010: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) today announced the start of the proof-of-concept Phase II study in treatment-resistant depression with its NR2B subtype selective NMDA receptor antagonist EVT 101. This clinical development is part of an alliance between Evotec and Roche (SIX: RO, ROG; OTCQX: RHHBY).

The proof-of-concept Phase II study with EVT 101, which is being conducted in the United States, has the main objective of studying the safety and tolerability of EVT 101 while also exploring the efficacy of this intervention. Approximately 100 patients suffering from treatment-resistant depression will participate in it. Treatment-resistance of patients will be confirmed in a 6-week prospective antidepressant treatment phase preceding the actual 4-week double-blind treatment.

Treatment-resistance to antidepressant drugs is observed in up to 30% of depressed patients. NMDA receptor antagonists represent an alternative mechanism that has the potential to improve depression in patients resistant to conventional antidepressants.

Dr Werner Lanthaler, Chief Executive Officer of Evotec AG, commented: "The clinical development of EVT 101 is addressing an area of significant unmet medical need, and this development represents a big market opportunity. We are happy to have Roche, as a recognised pioneer for novel solutions in the CNS area, for this development with us." 


About NMDA receptors in treatment-resistant depression

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. The non-selective NMDA receptor blocker ketamine and an NR2B-selective NMDA antagonist have shown in exploratory clinical trials the potential to provide 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. EVT 101 is an orally available compound which is well tolerated at dose levels considered to reach CNS levels which go along a high NMDA receptor occupancy. In a Phase I fMRI study performed with EVT 101 pharmacodynamic effects were seen at exposures similar to those planned for the ongoing proof of concept study.

About Evotec & Roche Alliance

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


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