The First Abscisic Acid-Containing Medical Food for Glycemic Control

Biotherapeutics Inc（BTI）是一家以科学为基础的生物技术公司，专门开发新的颠覆性 糖尿病和炎症的营养和治疗。BTI已授权弗吉尼亚州的11项专利申请 与糖尿病期间抑制炎症的新方法相关的技术，包括抗糖尿病的重要IP。 脱落酸（阿坝）的糖尿病作用。本项目的目标是开发阿坝作为医疗食品成分 并验证阿坝的有效剂量，改善糖尿病的血糖控制。 糖尿病影响着美国近2800万人，是第七大死亡原因。 国际吧仅在美国，每年治疗糖尿病的费用就超过1300亿美元， 最昂贵的疾病。根据《孤儿药法》， 肠内给药，用于确定特殊营养需求的疾病的饮食管理 它的饮食管理不能仅仅通过改变正常饮食来实现。 糖尿病患者患有不能通过正常饮食恢复的低血浆阿坝池。 我们的产品：BTI和其他人已经证明，补充阿坝是一种安全无毒的方法 改善小鼠、大鼠和人类的血糖控制，有效剂量低至1µg/kg， 副作用. SBIR第一阶段提案的目标是开发阿坝作为血糖控制的医疗食品成分。 控制这是一种创新的和具有成本效益的营养干预，用于控制血糖水平， 需要患者显著改变他们当前的生活方式或开始具有不良副作用的药物治疗方案。 具体目标是： AIM 1.开发符合GMP要求且具有成本效益的食品级阿坝生产新方法。 预期：阿坝产量为0.5 -1美元/克 AIM 2.评估阿坝PK特征、生物利用度、安全性和血糖控制的最低有效剂量。 预期：阿坝的安全和口服有效剂量为0.5-1µg/kg;在两个物种中验证。 AIM 3.探讨了日粮阿坝对小鼠的作用机制和细胞特异性。 期望：阿坝需要LANCL 2以细胞特异性方式进行治疗性葡萄糖摄取 SBIR第二阶段将集中在确保阿坝的一般安全（GRAS）状态， 一项在代谢综合征患者中进行的人类干预研究，以验证 用于血糖控制的阿坝制剂。含ABA的GlucaBridge™将与其他商业化的 用于血糖控制的营养产品，如临床试验中的Glucerna。 商业应用：这项工作将提供一个很好的评估的可行性， 用于血糖控制的新型品牌含ABA的GlucaBridge™，产品成本估计为 目前的替代品。到2018年，GlucaBridge™将颠覆90亿美元的医疗食品和580亿美元的糖尿病市场。

Biotherapeutics Inc (BTI) is a science-based biotech Company specialized in developing novel disruptive nutritionals and therapeutics for diabetes and inflammation. BTI has licensed 11 patent applications from Virginia Tech related to novel methods of suppressing inflammation during diabetes, including significant IP on the anti- diabetic actions of abscisic acid (ABA). The goal of this project is to develop ABA as a medical food ingredient and validate an effective dose of ABA that improves glycemic control in diabetes. Significance: Diabetes affects close to 28 million people in the U.S. and is the seventh leading cause of death worldwide. Annual expenses for treating diabetes exceed $130 billion per year in the U.S. alone making it one of the most expensive diseases. Under the Orphan Drug Act, a medical food is formulated to be consumed enterally for the dietary management of a disease for which distinctive nutritional requirements are established by medical evaluation, and its dietary management cannot be achieved by modification of the normal diet alone. Diabetic patients suffer from low plasma ABA pools that cannot be recovered through the normal diet. Our Product: BTI and others have demonstrated that supplementation with ABA is a safe and non-toxic method to improve glycemic control in mice, rats and humans with an effective dose as low as 1µg/kg and no adverse side effects. The goal of this SBIR Phase I proposal is to develop ABA as a medical food ingredient for glycemic control. This is an innovative and cost-effective nutritional intervention for controlling blood glucose levels without requiring patients to significantly alter their current lifestyle or initiate drug regimens with adverse side effects. The Specific Aims are to: AIM 1. Develop a new GMP-compliant and cost-effective method of food grade ABA manufacturing. Expectations: ABA production at $0.5-1/g AIM 2. Evaluate ABA PK profile, bioavailability, safety, and lowest effective dose for glycemic control. Expectations: Safe and orally active effective dose of ABA is 0.5-1µg/kg; validated in two species. AIM 3. Validate the mechanism of action and cell specificity of dietary ABA in mice. Expectations: ABA requires LANCL2 for therapeutic glucose uptake in a cell-specific manner The SBIR Phase II will be centered on securing Generally Regarded as Safe (GRAS) status for ABA, performing a human intervention study in patients with metabolic syndrome to validate safety, tolerability and efficacy of an ABA formulation for glycemic control. ABA-containing GlucaBridge™ will be compared to other commercialized nutritional products for glycemic control such as Glucerna in clinical trials. Commercial Application: This work will provide an excellent assessment of the feasibility of developing novel, branded ABA-containing GlucaBridge™ for glycemic control with product cost estimated at 50% under current alternatives. GlucaBridge™ will disrupt a $9B medical foods and $58B diabetes market by 2018.