The First Abscisic Acid-Containing Medical Food for Glycemic Control

Biotherapeutics, Inc., Blacksburg VA

Investigators

Abstract

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.