AZD3480 (TC-1734) is a novel small molecule that acts on the α4ß2 NNR subtype. In December 2005, we entered into a collaborative research and license agreement with AstraZeneca AB for the development and worldwide commercialization of AZD3480 as a treatment for various conditions marked by cognitive impairment, including Alzheimer’s disease and attention deficit/hyperactivity disorder (ADHD).
In May 2009, we announced preliminary results showing that AZD3480 met the primary outcome measure in a Phase 2 clinical trial in adults with ADHD. In September 2008, we and AstraZeneca announced that results from a Phase 2 clinical trial of AZD3480 in mild to moderate Alzheimer's disease were inconclusive. A decision by AstraZeneca with respect to the potential future development of AZD3480 in either or both of Alzheimer's disease and ADHD is expected in the second quarter of 2009.
In 2006, we completed a Phase 2b double blind, placebo controlled clinical trial of AZD3480 in age-associated memory impairment (AAMI), a common condition characterized by gradual memory loss or other cognitive impairment that generally occurs with normal aging. In the trial, we achieved statistically significant results in favor of AZD3480 on all three co-primary endpoints (the power of attention and episodic memory factors from the CDR test battery and a subject global impression scale) in the 50mg AZD3480 dose group and a statistically significant result in favor of AZD3480 on the power of attention endpoint in the 25mg AZD3480 dose group. AZD3480 was generally well tolerated as compared to placebo in the trial.
Based on the outcome of a Phase 2 clinical trial of AZD3480 in cognitive deficits in schizophrenia (CDS) completed in late 2008, AZD3480 is not expected to be advanced into Phase 3 clinical development in CDS.
As of May 2009, AZD3480 has been evaluated in approximately 1,350 subjects and has consistently exhibited a very favorable tolerability profile.
AZD1446 (TC-6683)
Phase 1 clinical development of AZD1446 (TC-6683), a product candidate selective for the alpha4beta2 NNR, was initiated by AstraZeneca in December 2008. AZD1446 is the most advanced compound arising out of our preclinical research collaboration with AstraZeneca. AstraZeneca is primarily responsible for and will fund costs for the development and commercialization of AZD1446.
About Alzheimer's disease
Alzheimer’s disease, the most common form of dementia, is a debilitating brain disorder for which there is no cure. The disease progresses in stages from mild to moderate to severe and gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. Mild Alzheimer’s disease is characterized by mild forgetfulness and difficulty acquiring basic information and communicating. Moderate Alzheimer’s disease is characterized by forgetfulness, failure to recognize friends and family, disorientation regarding time and place and personality changes. Severe Alzheimer’s disease is characterized by difficulty performing simple tasks and activities associated with daily living. Patients with severe Alzheimer’s disease require continuous care.
The treatment of Alzheimer’s disease is currently dominated by a class of drugs called acetylcholinesterase inhibitors. Acetylcholinesterase inhibitors have limitations in that only about half of Alzheimer’s disease patients who take them show symptomatic improvement, and the drugs do not substantially delay the progressive deterioration and death of cells in the brain that can lead to more severe impairment and debilitation.
The 2009 Alzheimer's Disease Facts and Figures report, issued by the Alzheimer's Association, estimates that there are more than 5.3 million Americans living with Alzheimer's disease, which is more than a 10% increase since 2002. The report also projects that, unless scientists discover a way to delay Alzheimer's disease, some 11 to 16 million Americans aged 65 and older will have the disease by 2050.
About Adult ADHD
ADHD is a condition that develops during childhood and, if not adequately treated, can have long-term adverse effects into adolescence and adulthood. The principal characteristics of ADHD are inattention, hyperactivity and impulsivity. For an adult to be diagnosed with ADHD, the ADHD symptoms must have begun during childhood and continued throughout adulthood. The market research firm Business Insights estimated that, in 2008, there were approximately 25 million adults with ADHD in the world’s seven major pharmaceutical markets.
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