FDA Grants Fast Track Designation for the Development of Oragenics’ AG013
The FDA has granted fast track designation to Oragenics’ drug candidate, AG013, for the treatment of oral mucositis.
AG013 is a therapeutic candidate formulated as an oral rinsing solution to deliver the therapeutic molecule Trefoil Factor 1 (TFF1) to the mucosal tissues in the oral cavity. TFF1 are involved in protection of gastrointestinal tissues against mucosal damage and have an important role in tissue repair.
Oragenics expects to file an investigational new drug update and initiate a phase II study with AG013 in the U.S. and Europe in early 2017.