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AntriaBio, Inc. (ANTB)

AntriaBio, Inc. is a biopharmaceutical company concentrating on developing novel extended release therapies. The company develops novel extended release therapies through combining proprietary formulation and manufacturing capabilities with well-known molecules to considerably improve standards of care. It develops innovative approaches to fulfill unmet clinical needs through applying its formulation capabilities to improve existing therapies.

AntriaBio's lead product candidate is AB101. This is an injectable once-weekly basal insulin for type 1 and type 2 diabetes. AB101 addresses a $10 billion market where the present standard of care is a once-daily basal insulin injection. AB101 is formulated from human recombinant insulin. This is different from existing basal insulin replacement therapies that use synthetic insulin analogues.

AB101 is now in preclinical development. It is to be administered by subcutaneous injection. AB101 is intended for use in patients with Type 1 and Type 2 diabetes who require basal insulin for the control of hyperglycemia. The design of the formulation is to release human insulin slowly and uniformly over a period of roughly one week without an adverse initial burst of insulin.

AntriaBio successfully completed a series of in vitro and multi-species animal pharmacology studies for AB101. The studies assessed the receptor pharmacology, pharmacokinetics, and pharmacodynamics of AB101 and support potential proof-of-concept for a once-weekly basal insulin in patients.

In September 2015, AntriaBio announced the addition of a new product candidate to the company's product development pipeline – AB301. As a potential treatment for patients with type 2 diabetes, AB301 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 (as of the September 16, 2015 press release) indicated that AB301 has the potential to be a well-tolerated, effective therapy for type 2 diabetes.

In November 2015, AntriaBio announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 14/324,734 titled, "Solvent Extraction From Biodegradable Microparticles." This application covers the methods around solvent extraction and rinse in the manufacturing process for product candidates AB101 and AB301, and also other internal and external potential pipeline therapies that use the company's proprietary microsphere drug delivery platform.




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