Could the same hormone that regulates your appetite keep you from developing Alzheimer’s? A 2009 study published in The Journal of the American Medical Association found that high levels of the hormone leptin were associated with lower rates of Alzheimer’s disease. Leptin, produced by fat cells, is believed to play a role in regulating appetite and weight. It has also been shown to reduce concentrations of B-amyloid, the protein that makes up the plaque deposits found in the brains of Alzheimer’s patients. In animal studies, leptin has been shown to improve memory performance in subjects with dementia.
Leptin is considered a relatively de-risked drug candidate, as previous human studies of Leptin for other indications have resulted in a substantial safety database. Only one commercial organization is currently known to be advancing a leptin product for Alzheimer’s disease: Neurotez, Inc. The New Jersey-based company’s recombinant leptin hormone therapy is formulated to treat individuals with Alzheimer’s and act as a preventative for high-risk patients. While other companies try to ameliorate the cognitive and behavioral symptoms of Alzheimer’s, Neurotez seeks to stop the disease at its source.
The company’s leptin therapy is in the early stages of clinical development; according to the company’s website, Neurotez plans to file an Investigational New Drug application with the U.S. Food and Drug Administration and initiate a biomarker trial between 2011 and 2012. A Phase II efficacy trial is expected to begin in the first quarter of 2012 and be completed by the first quarter of 2014. Big Pharma has historically demonstrated a willingness to enter into lucrative partnerships with smaller, research-based organizations that are developing Alzheimer’s compounds, which could make Neurotez an attractive option for a major pharmaceutical company seeking to develop its Alzheimer’s pipeline.
An estimated 5.3 million people in the U.S. have Alzheimer’s, and the National Alzheimer’s Association forecasts that direct and indirect costs of the disease will top $172 billion in 2010. The incidence of Alzheimer’s is expected to increase as America’s baby boomer population ages. Moreover, organization Alzheimer’s Disease International released a report last month projecting that the global incidence of Alzheimer’s will double by 2030 and more than triple by 2050. An estimated 35.6 million people worldwide currently have Alzheimer’s disease, which is expected to cost more than $604 billion worldwide in 2010.
Neurotez is scheduled to present at the OneMedForum SF 2011. For more information on the conference, visit http://www.onemedplace.com/forum.