AntriaBio filed an Investigational New Drug application with the FDA for their basal insulin treatment for diabetes mellitus patients. A trial is set to follow.
AntriaBio (OTCQB:ANTB) filed an Investigational New Drug application with the FDA for their basal insulin treatment for diabetes mellitus patients. A trial is set to follow.
As quoted in the press release:
The Company intends to subsequently initiate a Phase 1 first-in-human clinical study.
Preclinical studies of AB101 have demonstrated a comparable activity to regular human insulin in vitro and a weekly insulin time-action profile in animals, with no acute or delayed sudden insulin increase. These studies also suggest that an ultra long-acting insulin such as AB101 may potentially stabilize endogenous insulin-glucose homeostasis and reduce glycemic variability. These observations occurred at clinically relevant dose projections, demonstrating proof of concept of the potential for AB101 as a weekly subcutaneous basal insulin therapy for patients.
The 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.