AntriaBio, Inc.’s (OTCQB: ANTB) lead diabetes product candidate, AB101, is a once-a-week injectable basal insulin that is currently in preclinical development. AB101 is administered by subcutaneous injection and targets patients with type 1 and type 2 diabetes who require basal insulin for the control of hyperglycemia.
The formulation has been designed to release insulin slowly and uniformly over a period of approximately one week without an adverse initial burst of insulin. The release profile results in a low and sustained insulin level which supplements the effects of endogenous and exogenous insulin and complements the effects of orally administered hypoglycemic agents. AB101 has the potential to be a clearly differentiated product that represents a significant advance in basal insulin delivery.
AB101’s long duration of action is the result of our ability to PEGylate insulin and then encapsulate it into poly-lactic, poly-glycolic (PLGA) microspheres. Currently available PEGylated biomolecules typically use large molecular weight PEG chains to decrease clearance and therefore reduce injection frequency. However, we use a very small molecular weight PEG for AB101 to modify the solubility of insulin and permit encapsulation of the drug into a biodegradable polymer.
After injection, the PEGylated insulin is slowly released at the injection site as the polymer microspheres are broken down by simple hydrolysis. Not only is our technology is unique, but also AB101 does not contain any new excipients and regulatory authorities have already approved numerous products using PEG or biodegradable polymers.
In addition to the proprietary technology for PEGylation of insulin and incorporation of the PEGylated insulin into biodegradable polymers, we have licensed proprietary microparticle manufacturing technology. The microsphere manufacturing process ensures production of a very tight particle size distribution with uniformly small microparticles. This is important to improve manufacturing efficiency and yields as well as to facilitate patient comfort by producing microspheres that can be injected through 25 gauge or smaller needles.
Forward Looking Statements
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