On September 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported it has enrolled 158 patients in its Phase 2 trial of AG013 for the treatment of severe oral mucositis (Press release, Oragenics, SEP 25, 2019, View Source [SID1234539778]).
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In addition, the Data and Safety Monitoring Board (DSMB) for the trial, recently met and reviewed safety data to date and has determined that the trial may continue with no adjustments or further review. The company is currently enrolling approximately 200 patients in 59 study sites in the United States and Europe.
"Having reached more than three quarters enrollment is an important milestone for this trial, and we remain on track to complete enrollment by the end of the fourth quarter of 2019. In the meantime, we are grateful to our DSMB for their continued support in reviewing our incremental safety data and clearing the trial to continue uninterrupted. Finally, we look forward to providing additional updates on the progress and data from the trial as it becomes available," stated Alan Joslyn, CEO of Oragenics, Inc.
AG013, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an ActoBiotics therapeutic candidate formulated to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. The compound was designed by the company’s strategic partner, ActoBio Therapeutics, Inc., a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON).