AntriaBio provided an update on its pipeline and development plans, including a delay in the timeline for preclinical once-weekly basal insulin candidate AB101, in a recent letter to shareholders. The letter noted that AntriaBio has completed all preclinical studies for AB101, including PK/PD studies in rats and dogs that support once-weekly dosing (presented at ADA 2015) and toxicity studies. The company now expects to file an Investigational New Drug application (IND) in 2Q16 and begin the first in-human trials of AB101 in 3Q16. This is a delay from the previous expectation of an IND filing in 2015 and the first in-human trials in 2H15. On the positive side, this latest update noted that the company has completed construction of a cGMP manufacturing suite and expects to manufacture clinical material in 4Q15 and 1Q16. The letter also highlighted AntriaBio’s second pipeline candidate AB301, a preclinical once-weekly GLP-1 agonist/basal insulin for type 2 diabetes, which was first announced in September. Additional novel pipeline products will be announced in the next 12-18 months, and we certainly hope to see AntriaBio continue its focus on diabetes. Now that Sanofi has licensed Hanmi’s portfolio of long-acting GLP-1 agonist and insulin candidates, we imagine that AntriaBio could be an appealing partner for Lilly or Novo Nordisk in the future, though that is very highly speculative at this point. PhaseBio also has a once-weekly basal insulin candidate in phase 2a and a once-weekly basal insulin/GLP-1 agonist combination in preclinical development.
-- by Helen Gao, Emily Regier, and Kelly Close