AntriaBio's lead diabetes product candidate, AB101, is a once-weekly injectable basal insulin for use in patients with type 1 and type 2 diabetes for the control of hyperglycemia.
AB101's formulation has been designed to release human insulin slowly and uniformly over a period of approximately one week without any adverse burst of insulin. The release profile results in a sustained and near peak-less insulin level over the intended treatment period, 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 would represent a significant advance in basal insulin therapy.
Preclinical proof of concept has been demonstrated in three animal species - dogs, rats and diabetic mini-pigs. An Investigational New Drug (IND) application for AB101 will be filed in June 2017. The subsequent first-in-human Phase 1 study will assess the safety and tolerability, pharmacokinetics and time-action profile of single ascending doses of AB101, administered to subjects with type 1 diabetes mellitus. Prosciento, formerly known as Profil Institute for Clinical Research, will conduct the study.