Evotec AG has began 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.
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 six-week prospective antidepressant treatment phase preceding the actual 4-week double-blind treatment.
Treatment-resistance to antidepressant drugs is observed in up to 30 per cent 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."
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.