GLP Pre clinical Rodent Studies of ZAG as an Anti-obesity, Anti-Diabetic Therapeu

描述（由申请人提供）：Halsa已获得ZAG的独家知识产权，ZAG是一种天然存在于人体中的材料，可立即大量消耗体内脂肪并控制糖尿病症状。越来越多的证据表明，这种治疗方法可以消耗体内脂肪。超过65%的美国人超重或肥胖，这些疾病的成本估计为1500亿美元（实际医疗保健成本的一半），有效的处方减肥治疗市场估计为每年180亿美元。Halsa组建了一支世界一流的团队，在药物开发方面具有确切的专业知识。该项目将为ZAG进入完整的临床前试验奠定基础，以准备向FDA提交IND申请以及随后的临床试验。该SBIR I期项目将在大鼠中进行探索性GLP毒理学研究，这是了解这种有前途的治疗药物可能责任的关键一步。该项目的三个具体目标是：生物制剂的生产，其效力的测定和毒理学研究，包括组织病理学。 公共卫生相关性：肥胖和超重是流行病，危险，昂贵，基本上未经治疗。Halsa正在开发一种生物药物ZAG，这是一种天然存在于人体中的材料，可立即大量消耗体内脂肪，并控制糖尿病症状。这种治疗候选药物有可能治疗近2亿患有这些有害代谢疾病的美国人。

DESCRIPTION (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 growing 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 prescription 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 preparation 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 three 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 untreated. 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 nearly 200 million Americans afflicted with these deleterious metabolic diseases.