Galera therapeutics, inc. announces full results from the 223-patient, randomized, double-blind phase 2b clinical trial of lead candidate gc4419

Galera therapeutics, inc. announced that full results from the 223-patient, randomized, double-blind phase 2b clinical trial of lead candidate gc4419 (avasopasem manganese) in patients with locally advanced head and neck cancer have been published in the journal of clinical oncology, a journal of the american society of clinical oncology (asco). data in the paper, titled, “phase iib, randomized, double-blind trial of gc4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer,” demonstrated that adding a 90 mg dose of gc4419 to a standard radiotherapy regimen produced a significant reduction of severe oral mucositis (som) duration from 19 days to 1.5 days (92%), and improvement in som incidence through completion of radiation by 34% and improvement in oral mucositis (om) severity (grade 4 om incidence) by 47%. galera’s lead product candidate, gc4419 (avasopasem manganese), is a potent and highly selective small molecule dismutase mimetic that is being developed for the reduction of som. gc4419 is designed to rapidly convert superoxide to hydrogen peroxide, reducing mucosal damage and thereby the incidence and severity of mucositis. left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis, which can limit the anti-tumor efficacy of radiation therapy. gc4419 is being studied in the phase 3 roman trial for its ability to reduce the incidence, severity and duration of som in patients with locally advanced head and neck cancer, its lead indication. in galera’s 223-patient, double-blind, randomized, placebo-controlled phase 2b clinical trial, gc4419 demonstrated the ability to reduce the duration of severe oral mucositis (som) from 19 days to 1.5 days (92%), the incidence of som through completion of radiation by 34% and the severity of patients’ om by 47%, and gc4419 was well tolerated in the trial when added to a standard radiotherapy regimen. the two-year tumor outcomes follow up of patients enrolled in the trial also demonstrated that gc4419, when added to a standard radiotherapy regimen, maintained the efficacy of treatment, with tumor outcomes maintained across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival – in both gc4419 dose groups (30 mg and 90 mg) compared to placebo. gc4419 is also currently being studied in combination with sbrt for its anti-tumor effect in a pilot phase 1b/2a trial of patients with locally advanced pancreatic cancer. in addition, in multiple preclinical studies, gc4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue. the u.s. food and drug administration granted fast track and breakthrough therapy designations to gc4419 for the reduction of the duration, incidence and severity of som induced by radiotherapy.
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