MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced the first patient has been dosed in a pilot Phase 2 clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to improve 28-day mortality in hospitalized patients who are critically ill with COVID-19.
GC4419 is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen.
“The unprecedented medical need of this pandemic has prompted many companies in our industry to test the potential utility of their technology to help fight this infection,” said Mel Sorensen, M.D., President and CEO of Galera.
“Our corporate mission continues to be that of transforming radiotherapy, and we remain focused on progressing our ongoing trials, most notably, our Phase 3 ROMAN trial for the reduction of radiation-induced severe oral mucositis in patients with head and neck cancer, as well as our Phase 2 anti-cancer trial in locally advanced pancreatic cancer in combination with stereotactic body radiation therapy. We look forward to exploring the potential of GC4419 in patients who are critically ill with COVID-19 while maintaining a disciplined approach to our resource allocation in support of this trial.”
The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo. The trial will enroll up to 50 hospitalized adult patients critically ill with COVID-19 at several sites across the U.S. Patients in the trial will receive 90 mg of GC4419 or placebo by infusion twice daily for seven days. The trial will also collect additional data related to the requirement for intensive care, mechanical ventilation, and organ function.
“Superoxide is reported in internal and published data to play a causative role in the progression of the hyperinflammatory phase of this infection, sometimes referred to as cytokine storm. Galera’s dismutase mimetics have shown the ability in preclinical models to protect the lungs and other organs from damage caused by excessive and prolonged superoxide production,” said Dennis Riley, Ph.D., Chief Scientific Officer of Galera.
“Based upon the guidance of experts in pulmonary disease and viral infections, we have worked with the FDA to initiate this trial having recognized the importance of potentially contributing to the care of those affected by COVID-19.”
Multiple preclinical models suggest that by removing superoxide, GC4419 can potentially break the hyperinflammatory cycle, and reduce acute inflammatory lung injury and acute respiratory distress syndrome (ARDS). In preclinical models, GC4419 has shown it can prevent superoxide damage to the lungs by radiation therapy and other injuries.
Other preclinical models also suggest that removing superoxide to inhibit the hyperinflammatory cycle might reduce COVID-19 damage to other organs and the related hypotension.
For additional information about the trial, visit www.galeratx.com.
Galera Therapeutics, Inc., headquartered in Malvern, PA, is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer.
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