GLP Pre clinical Rodent Studies of ZAG as an Anti-obesity, Anti-Diabetic Therapeu
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HALSA PHARMACEUTICALS, INC., 8822 WESTVIEW DR, HOUSTON, TX, 77055
AbstractDESCRIPTION (provided by applicant): Halsa has acquired the exclusive intellectual property rights to ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat as well as control of diabetic symptoms. A growin g set of evidence shows that this therapeutic works in depleting body fat. Over 65% of Americans are overweight or obese, the costs of these conditions is estimated as 150 billion (half in actual health care costs), and the market for an effective prescri ption weight-loss therapeutic is estimated at 18 billion annually. Halsa has assembled a world-class team with exact domain expertise in pharmaceutical drug development. This project will lay the foundation for ZAG to enter full preclinical trials in prep aration of an IND filing with the FDA, and subsequent clinical trials. This SBIR Phase I project will result in exploratory GLP toxicological studies in rats, a critical step in understanding possible liabilities for this promising therapeutic agent. The t hree specific aims of this project are: manufacture of the biologic agent, determination of its potency and toxicology studies including histopathology. PUBLIC HEALTH RELEVANCE: Obesity and overweight are epidemic, dangerous, expensive and largely u ntreated. Halsa is developing a biological drug, ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat and also controls symptoms of diabetes. This therapeutic candidate has the potential to treat the near ly 200 million Americans afflicted with these deleterious metabolic diseases.
* information listed above is at the time of submission.