Memorandum
Earlier this week, AntriaBio announced closure of a $13 million round of private funding, which will be used to advance phase 1 long-acting basal insulin candidate AB101 (PEGylated insulin), among other pipeline products and corporate endeavors. Investors in this round of financing included South Korea-based Aju Pharm, Ildong Pharmaceutical Company, and the Medici Investment Company. After several delays, AntriaBio submitted an Investigational New Drug Application (IND) to the FDA last month, which was accepted for active review on July 1 (we were pleased to see this forward progress). This recent funding will allow the company to proceed with a phase 1 clinical trial, and the first patient is expected to be dosed by end of month. According to AntriaBio’s announcement of IND filing, the phase 1 study will be conducted by San Diego-based Prosciento (formerly the Profil Institute for Clinical Research). If AB101 can show convincing safety and efficacy compared to daily basal insulin products, this new therapy could certainly be a win for people with diabetes – it would offer substantially lower injection burden and improved convenience and patient quality of life. That said, achieving a PK/PD profile that lasts seven full days safely is no small feat, given insulin’s narrow therapeutic range and hypoglycemia risk. Moreover, bringing an insulin product to market also means entering a challenging pricing environment in an extremely competitive field. For more, see our insulin competitive landscape. Lilly also has a long-acting basal insulin with potential for once-weekly dosing in phase 1, as does Novo Nordisk. Sanofi/ Hanmi’s LAPSInsulin-115 is also in phase 1 and is expected to be a once-weekly formulation. AntriaBio has another promising candidate in AB301, a preclinical basal insulin/GLP-1 agonist fixed-ratio combination that aims for once-weekly dosing.
-- by Ann Carracher, Payal Marathe, and Kelly Close