AG013, a therapeutic candidate of ActoBiotics, is being developed as an oral rinsing solution to deliver Trefoil Factor 1 peptides to the mucosal tissues in oral cavity for protection against damage.
The double-blind, placebo-controlled Phase II trial will investigate the efficacy, safety and tolerability of AG013 in approximately 200 patients at 30 centres in the US and Europe.
Intended to evaluate the investigational candidate’s ability to reduce the mucositis in subjects receiving chemo radiation for head and neck cancer, the trial will measure the duration, time to development and overall incidence of OM.
Oragenics president and CEO Alan Joslyn said: “We are very excited to dose the first patient and initiate the Phase II trial of AG013 for oral mucositis, one of the most common and debilitating complications of chemo-radiation therapies.
“With no approved preventative treatment, oral mucositis represents a serious unmet need that we hope to help overcome.”
It is expected that the preliminary data from an initial 20 patients will be reported by the end of this year, while full results are anticipated by the end of next year.
Designed by the firm’s partner Intrexon, AG013 secured fast-track designation in November last year from the US Food and Drug Administration (FDA).
As per an exclusive channel collaboration agreement with Intrexon, Oragenics holds a worldwide licence for the development and commercialisation of AG013 for OM in cancer patients.