dapatifagene navolactibac (AG013) / Oragenics - LARVOL DELTA

Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day (clinicaltrials.gov) - P2; N=200; Terminated; Sponsor: Oragenics, Inc.; Trial completion date: Mar 2021 ➔ Jul 2020; Active, not recruiting ➔ Terminated; No efficacy could be demonstrated, sponsor decided to prematurely end the study.

Clinical • Trial completion date • Trial termination • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Oragenics, Inc. announces early top-line results of phase 2 clinical trial of AG013 for oral mucositis in chemoradiation treatment of head and neck cancer (Businesswire) - P2, N=NA; “Oragenics, Inc…announced today that early top-line results of the company’s Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo. AG013 was found to be safe based on review of topline adverse event information.”

P2 data • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor

Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: Oragenics, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial completion date

"Oragenics, Inc. Provides Development Update of AG013 for Oral Mucositis https://t.co/WZdRK0pEUN" (@NewsFromBW)