Biotherapeutics, Inc. — Department of Health and Human Services SBIR Phase I: 200

Description

Biotherapeutics Inc BTI is a science based biotech Company specialized in developing novel disruptive nutritionals and therapeutics for diabetes and inflammation BTI has licensed 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 million people in the U S and is the seventh leading cause of death worldwide Annual expenses for treating diabetes exceed $ 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 g 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 Develop a new GMP compliant and cost effective method of food grade ABA manufacturing Expectations ABA production at $ g AIM Evaluate ABA PK profile bioavailability safety and lowest effective dose for glycemic control Expectations Safe and orally active effective dose of ABA is g kg validated in two species AIM Validate the mechanism of action and cell specificity of dietary ABA in mice Expectations ABA requires LANCL 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 under current alternatives GlucaBridge will disrupt a $ B medical foods and $ B diabetes market by Abscisic acid ABA has demonstrated outstanding efficacy in improving glycemic control but even though its concentration in some fruits is high the amount of ABA available in the normal diet alone is insufficient to provide an effective control of blood glucose levels Given that of adults in the U S have metabolic syndrome obesity pre diabetes or diabetes have low levels of ABA in metabolic pools an ABA containing medical food developed under this project will address the overlying health problems of over million US consumers with a market of $ B annually by