Evotec AG: Phase II study with NR2B sub-type selective NMDA antagonist in treatment-resistant depression voluntarily terminated

Wednesday, 18. May 2011 11:33
Evotec AG /
Evotec AG: Phase II study with NR2B sub-type selective NMDA antagonist in
treatment-resistant depression voluntarily terminated
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Hamburg, Germany - 18 May 2011: Evotec AG (Frankfurt Stock Exchange: EVT,
TecDAX) and Roche (SWX: RO, ROG; OTCQX: RHHBY) today decided to voluntarily
terminate the first proof-of-concept study in treatment-resistant depression
with their NR2B sub-type selective NMDA antagonist EVT 101.
The decision to terminate this Phase II study was triggered by difficulties to
recruit patients under the current study protocol, resulting in the possibility
of inconclusive results. EVT101 was generally well tolerated in healthy
volunteers and patients enrolled so far. Difficulties in conducting this Phase
II study in treatment resistant depression, the need to sharpen the toxicology
profile and a potential requirement for an altered dosage scheme lead to an
overall delay in the programme. Based on this, the parties concluded to
terminate the clinical development.
This clinical development has been the key part of an alliance between Evotec
and Roche in which Roche has provided all funding in exchange for certain option
rights after a proof-of-concept result with NR2B sub-type selective NMDA
antagonist in treatment-resistant depression.
Evotec retains all rights in the EVT100 series, especially the back-up compound
EVT103, and will enter into partnering discussions for these assets in another
clinical development partnership. As advanced clinical development of drug
candidates is not part of Evotec's core business, Evotec does not intend to
pursue further clinical development of its NR2B sub-type selective NMDA
antagonist without a partner.

About NMDA receptors in treatment-resistant depression and EVT 101

NMDA receptors are involved in the pathology of depression and other CNS
diseases. 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 been proven
to provide substantial and instant clinical benefit for patients. However, both
molecules, for which proof of concept has been shown before, require parenteral
administration, hence an orally active therapeutic option is needed. The proof
of concept Phase II study with EVT 101 was designed as a double-blind, placebo-
controlled, randomized study performed with approximately 100 patients suffering
from treatment-resistant depression. Treatment-resistance of patients was to be
confirmed in a 6-week prospective antidepressant treatment phase preceding the
actual double-blind treatment, which last 4 weeks. The main endpoints of the
study were safety, tolerability, and efficacy. The antidepressant effect was
assessed using MADRS and other rating scales.

Contact Evotec AG: Dr Werner Lanthaler, Chief Executive Officer, Phone:
+49.(0)40.56081-242, werner.lanthaler@evotec.com

Forward-Looking Statements - Information set forth in this press release
contains forward-looking statements, which involve a number of risks and
uncertainties. The forward-looking statements contained herein represent the
judgement of Evotec as of the date of this report. Such forward-looking
statements are neither promises nor guarantees, but are subject to a variety of
risks and uncertainties, many of which are beyond our control, and which could
cause actual results to differ materially from those contemplated in these
forward-looking statements. We expressly disclaim any obligation or undertaking
to release publicly any updates or revisions to any such statements to reflect
any change in our expectations or any change in events, conditions or
circumstances on which any such statement is based.

--- End of Message ---

Evotec AG
Schnackenburgallee 114 Hamburg Germany

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