Evotec's EVT 101 Well Tolerated in Four Week Higher Repeat Dose Safety Study
HAMBURG, Germany, July 3, 2008 -Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) announced today top-line results of a double-blind, 4-week Phase Ib study with EVT 101, an orally active NR2B-subtype selective antagonist of NMDA receptors with potential in Alzheimer's disease, neuropathic pain and other indications. The study showed in both young and elderly subjects that the drug was well tolerated up to the highest dose tested.
The study was designed to evaluate safety/tolerability, pharmacokinetics, and pharmacodynamics during prolonged dosing with EVT 101 as com-pared to placebo, but at higher dose levels and for a longer duration that the previously completed Phase I study. The study was conducted and completed as planned per protocol.
EVT 101 was administered to 48 young and elderly healthy subjects over four weeks. Up to the highest dose level (12 mg/day in elderly, 15 mg/day in young subjects) EVT 101 was well tolerated by both populations. No severe or serious adverse events were reported, and only few transient, mostly mild, adverse events occurred. This safety and tolerability profile is extremely encouraging as the doses evaluated are predicted to be well into the anticipated therapeutic range. As previously reported (see press re-lease, March 28, 2008), this trial contained a sub-study in which drug CSF levels were measured to determine the extent of brain penetration.
Psychometric tests, examining different aspects of cognitive function, revealed a mixed pattern of minor transient changes, as expected from populations of healthy subjects performing optimally in cognitive tasks.
"Together with results from the fMRI brain imaging which we announced in March, these results provide a robust Phase Ib package. We have found doses of this highly specific compound that achieve a high level of brain exposure to achieve a high level of NR2B receptor blockade. These doses produce specific modulation of relevant brain areas and, importantly, are also well tolerated. This provides a good foundation for moving forward with the clinical development of this compound and enables us to investigate EVT 101 in relevant patient groups," commented Dr Tim Tasker, Executive Vice President Clinical Development, Evotec AG.
About Evotec AG
Evotec is a leader in the discovery and development of novel small molecule drugs. Both through its own discovery programs and through research collaborations, it is generating the highest quality research results to its partners in the pharmaceutical and biotechnology industries. In proprietary projects, Evotec specializes in finding new treatments for diseases of the Central Nervous System. Evotec has three programs in clinical development: EVT 201, a partial positive allosteric modulator (pPAM) of the GABAA receptor complex for the treatment of insomnia, EVT 101, a subtype selective NMDA receptor antagonist for the treatment of Alzheimer's disease and/or pain, and EVT 302, a MAO-B inhibitor in development for smoking cessation. Evotec's proprietary preclinical research programs focus on the purinergic receptors, P2X3 and P2X7, for the potential treatment of pain and inflammatory diseases. In addition, Evotec has worldwide collaboration and license agreements with Pfizer to research, develop and commercialize small molecule vanilloid receptor (VR1) antagonists. For additional information please go to www.evotec.com <http://www.evotec.com/>
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Evotec AG Hamburg. Amtsgericht Hamburg HRB 68223 Vorstand: Jörn Aldag (Vorsitzender) Dr. Klaus Maleck Dr. Mario Polywka Aufsichtsratsvorsitzender: Prof. Dr. Dr. h.c. mult. Heinz Riesenhuber
Posted: July 2008