The single ascending dose study is designed to test the safety, pharmacokinetics and dynamics of AB101 in patients with Type I diabetes.
The second part of the study is slated to compare AB101 to Sanofi‘s (NYSE:SNY) Lantus insulin glargine. Researchers will assess AB101’s time-related qualities, including onset, peak and end-of-action, according to the Louisville, Colo.-based company.
AntriaBio said it expects high-level results as soon as the fourth quarter of this year.
“The successful filing of the IND followed by initiation of the first-in-human clinical trial for AB101 are significant milestones for our company as these events validate our robust preclinical results and bring us to the doorstep of being able to demonstrate clinical proof-of-concept for AB101 as a once-weekly insulin,” Dr. Brian Roberts, VP of clinical development, said in prepared remarks.
“Based on animal data, AB101 has the potential to improve overall glycemic control in patients with diabetes while offering a more convenient injection regimen compared to currently available basal insulins. The availability of such a therapy could optimize initiation and adherence to insulin and provide an important treatment option for patients and providers at a time when diabetes continues to increase to historic proportions.”