Galera Therapeutics has dosed the first patient in a Phase III clinical trial of avasopasem manganese (GC4419).
The trial will evaluate the safety and tolerability of GC4419 in lowering the incidence and severity of radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer.
The randomised, double blind, placebo-controlled trial is expected to enrol around 335 adult patients.
To qualify, patients will be receiving seven weeks of radiation therapy plus cisplatin to treat locally advanced, non-metastatic squamous cell head and neck cancers.
It will be conducted across more than 70 trial sites in the US and Canada.
As part of the trial, patients will be randomised in 3:2 ratio to one of the two treatment groups. They will receive either 90mg of avasopasem manganese or placebo by infusion on the days of their radiation treatment.
Galera’s avasopasem manganese is a highly selective and potent small molecule dismutase mimetic. It is designed to reduce elevated levels of superoxide caused by radiation therapy.
Patients will be observed for tumour progression and overall survival.
The trial’s primary objective is the reduction in the incidence of severe oral mucositis (SOM) during the treatment period, while the secondary objective focuses on reducing the severity of SOM.
Galera Therapeutics CEO Mel Sorensen said: “Our meetings with both the FDA and European Medicines Agency have been productive and have provided a clear path for the registration of avasopasem manganese.
“We anticipate enrolment to take less than two years, and we will refine our timeline as the trial progresses.”
In the US, more than 50% of cancer patients receive radiotherapy at some point in their treatment. Around 70% of these patients develop SOM, which is the most devastating side-effect of radiotherapy.
Currently, there is no drug approved to prevent or treat SOM.