Investor Relations Overview
AntriaBio (OTCQB: ANTB) is focused on developing novel therapies that combine its proprietary formulation and manufacturing capabilities with well-known molecules to improve the current standard of care. AntriaBio's lead product candidate, AB101, a recombinant human basal insulin formulated for once-weekly injection, has the potential to significantly advance the current treatment paradigm for insulin replacement therapy.
Basal insulin is the background insulin that is continually released by the pancreas, and controls blood sugar levels between meals and overnight. The current basal insulin standard of care for diabetic patients is a once-daily injection. In preclinical studies, AB101 demonstrated encouraging positive results. If approved, AB101 could make significant inroads in the $11 billion basal insulin market, and meaningfully improve the quality of life for diabetic patients by reducing their burden from seven injections to one injection per week.
In September 2015, AntriaBio announced the addition of a successfully formulated new product candidate to its product development pipeline. As a potential treatment for patients with type 2 diabetes, AB301 is a once-weekly injectable combination of a PEGylated human glucagon-like peptide-1 (GLP-1) agonist and AB101. The company believes that there is a potential advantage of combining a GLP-1 agonist with basal insulin to complement glycemic control while attenuating weight gain and hypoglycemic risk. As a once-weekly injectable therapy, AB301 would be differentiated from combination therapies that are currently in clinical development and require daily injections. In vitro and in vivo studies completed to date indicate that AB301 has the potential to be a well-tolerated, effective therapy for type 2 diabetes. AntriaBio is currently engaged in ongoing preclinical studies of AB301.
- The International Diabetes Federation estimates over 590 million people globally will be living with diabetes by 2035, many of whom may require basal insulin.The International Diabetes Federation estimates over 590 million people globally will be living with diabetes by 2035, many of whom may require basal insulin.
- Over $100 million was invested by PR Pharmaceuticals, the company whose assets AntriaBio acquired, in technology development, process scale-up and development of therapies, including AB101.
- AntriaBio has successfully raised more than $20 million to date.
- AB101, AntriaBio’s lead product candidate, consists of a uniform microsphere formulation of PEGylated human recombinant insulin and PLGA, a biodegradable polymer that is critical for the sustained release over a 7 day dosing interval.
- AntriaBio’s VP of Clinical Development, Brian Roberts, M.D., presented preclinical results for AB101 in an oral presentation session at the American Diabetes Association 75th Scientific Sessions® in Boston. The results demonstrated that AB101 has comparable in vitro pharmacology to native insulin, and in two animal species exhibited a prolonged subcutaneous insulin absorption profile, resulting in slow onset and sustained insulin levels and glucose reduction, without acute hypoglycemia caused by an insulin burst. These observations occurred at clinically relevant dose projections, demonstrating proof of concept of the potential for AB101 as a weekly subcutaneous basal insulin therapy in patients with diabetes mellitus.
- AntriaBio anticipates that an Investigational New Drug (IND) application for AB101 will be filed with the FDA by the end of Q2 2016. Following the FDA's acceptance of the IND application, AntriaBio will subsequently commence the phase 1 study in type 1 and type 2 diabetes patients.
- AntriaBio's corporate development strategy involves developing new product candidates by applying proprietary formulation and manufacturing capabilities to known and well-characterized molecules for disease states where there is a clinical need for longer-acting therapies.
- AB301, AntriaBio's next product candidate, is a weekly injectable combination of a pegylated human glucagon-like peptide-1 (GLP-1) agonist and AB101, AntriaBio's basal insulin lead product candidate. In vitro and in vivo studies completed to date indicate that AB301 has the potential to be a well-tolerated, effective therapy for patients with type 2 diabetes.