German drug developer Evotec AG (EVTCY.PK) announced Wednesday that the U.S. Food and Drug Administration, or FDA, has given permission to initiate a phase II proof of concept study with its investigational depression drug EVT 101.
The phase II proof of concept studstudy would commence recruitment of patients in the second quarter, according to the company.
Evotec also said that it has completed clinical part of first phase I study with EVT 103, which has been found to be safe and very well tolerated. EVT 103 is a follow on molecule to EVT 101. The first in man phase I study with EVT 103 was commenced in September 2009.
The phase I double-blind, placebo-controlled, randomized ascending dose study enrolled 72 healthy young male subjects. The endpoints of the study were safety, tolerability and pharmacokinetic profile post drug administration. In addition, the effect of food on the pharmacokinetics of EVT 103 was investigated. EVT 103 was safe and very well tolerated, with "excellent" bioavailability and only a minimal effect of food on the kinetic profile.
The company noted that these "positive aspects" would strengthen its integrated product development in treatment-resistant depression in its strategic alliance with Swiss pharma, Roche. Evotec is developing EVT 101 and EVT 103 in partnership with Roche Holding Ltd. (RHHBY.PK) in treatment-resistant depression.
Treatment-resistant depression is a term used in clinical psychiatry to describe cases of major depressive disorder that do not respond to adequate courses of at least two antidepressants. More than 120 million people are estimated to suffer from depression globally. According to the National Institute for Mental Health, some of the symptoms include persistent sad, anxious or "empty" mood, feelings of hopelessness or pessimism, feelings of guilt, worthlessness or helplessness, or loss of interest or pleasure in hobbies and activities that were once enjoyed. Currently there are no approved monotherapy for treatment-resistant depression.
In March 2009, FDA approved Eli Lilly and Co.'s (LLY) Symbyax, an olanzapine and fluoxetine HCl capsule. According to Eli Lilly, Symbyax is the first drug approved by the FDA for the acute treatment of treatment-resistant depression.
Apart from Roche, Evotec has long-term discovery alliances with partners including Boehringer Ingel-heim, CHDI, Pfizer Inc. (PFE), Biogen Idec Inc. (BIIB), Novartis AG (NVS), Ono Pharmaceutical (OPHLF.PK) and InterMune, Inc (ITMN).
In November 2009, Evotec voluntarily delisted its American Depositary Shares from the NASDAQ stock market to concentrate its share trading on the TecDAX platform. During the second quarter of 2008 Evotec acquired Renovis and, in the context of the transaction, listed on NASDAQ, under the ticker "EVTC".
Tuesday, EVTCY.PK closed regular trading at $5.43 and RHHBY.PK finished at $41.90, on the OTC. LLY finished Tuesday's session at $35.06, on the NYSE.
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