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Depression

Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. At its worst, depression can lead to suicide, a tragic fatality associated with the loss of about 850,000 lives every year.

Depression is among the leading causes of disability worldwide, affecting approximately 121 million people. By the year 2020, depression is projected to reach 2nd place of the ranking of DALYs calculated for all ages, both sexes, according to the World Health Organization (WHO). Today, depression is already the 2nd cause of DALYs in the age category 15-44 years for both sexes combined.

Depression can be reliably diagnosed in primary care. Anti-depressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.

These medications are the subject for many studies and competing claims about their effectiveness and adverse effects. Most produce an anti-depressant effect, however restrictions on their use have caused controversy and off-label prescription a risk, despite claims of superior efficacy.

Anavex is developing a novel treatment for depression, aiming to improve the lives of the millions of people suffering for this mental disorder.

ANAVEX 1-41
A new compound in the advanced preclinical phase for the treatment of depression and fatigue

Mode of action: ANAVEX 1-41 presents mixed pharmacological activity involving serotoninergic, sigma-1 and sodium channel components suggesting a prototype mechanism of action and representing a new class of anti-depressants.

Results to date: ANAVEX 1-41 exhibited an outstanding profile in the Forced Swim Test (FST) (80 – 100% of anti-immobility at 100 mg/kg, per os) suggesting anti-depressant properties that have not been observed so far with any of the currently available anti-depressants. In addition, ANAVEX 1-41 demonstrated anti-convulsive action (ED50 = 50 – 100 mg/kg per os).

Moving forward: The company has initiated scale-up manufacturing of ANAVEX 1-41, its second lead compound for a range of important CNS diseases. With sufficient quantities of ANAVEX 1-41 in hand we will be in a position to advance the program and begin preclinical studies on large animals in the near term. This is expected to take ANAVEX 1-41 an important step closer to Phase 1 trials in humans.

The required quantities of ANAVEX 1-41 will be manufactured by Syntagon AB under GMP conditions, the quality assurance system required in the production of medicinal products.

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