AntriaBio (OTC:ANTB) said today that it filed an investigational new drug application with the FDA for its once-weekly basal insulin.
If the Louisville, Colo.-based company wins approval from the FDA, it plans to launch a Phase I clinical trial of AB101 in patients with Type I diabetes.
The first-in-human study is slated to evaluate the safety, tolerability, pharmacokinetics and time-action profile of the once-weekly basal insulin.
Preclinical studies of AB101 have shown comparable activity to regular human insulin. The company said it has seen no acute or delayed sudden increases of insulin in its preclinical work.
The company’s studies also suggest that an ultra long-lasting insulin may stabilize endogenous insulin-glucose homeostasis and lessen fluctuations in blood sugar levels, AntriaBio reported.
“Following the positive data from our preclinical proof of concept studies in 3 animal species, we are excited for AB101 to enter the clinic as this is the next critical step along the path to achieve our ultimate goal of providing an important new treatment option for patients suffering with diabetes,” chairman & CEO Nevan Elam said in prepared remarks.