US-based biotechnology company Galera Therapeutics has concluded enrolment in the Phase IIb clinical trial of GC4419 for the treatment of oral mucositis (OM) in patients with head and neck cancer.
GC4419 is a selective, small-molecule dismutase mimetic currently being developed to quickly convert superoxide into hydrogen peroxide to prevent the damaging effects that radiation might have in normal tissue.
The double-blind, randomised, controlled Phase IIb trial recruited a total of 223 patients who are on chemoradiation therapy.
Initiated in January last year, the trial is designed to assess the efficacy, safety and tolerability of either 30mg or 90mg of GC4419 in minimising the incidence and duration of OM.
The subjects will be administered with the product on the days they undergo their radiation treatment.
Galera Therapeutics president and CEO Mel Sorensen said: "We are pleased with the rapid enrolment, as well as investigator and patient enthusiasm for this trial.
“This trial is intended to identify a safe and effective dose of GC4419 and, if positive, will guide the design of our Phase III clinical programme."
The trial’s primary outcome is the measure of the duration of severe OM experienced by patients who receive seven weeks of radiation therapy and cisplatin, while the secondary endpoint includes incidence of severe OM.
The top-line results from the Phase IIb trial are expected in the fourth quarter of this year.
The findings reported by the firm in September last year from a Phase Ib/IIa trial showed that the product significantly decreased the duration and incidence of severe OM compared to historical control, and was generally safe and well tolerated.