Galera Therapeutics has dosed the first patient in a Phase IIa clinical trial of its product candidate avasopasem manganese (GC4419).
The study will evaluate the efficacy of GC4419 in lowering the incidence of radiation-induced esophagitis among lung cancer patients.
The open-label, multi-centre trial will include around 60 adult patients with pathologically confirmed unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers.
Subjects will be treated with 90mg of avasopasem manganese by infusion on the days they undergo radiation therapy. The study is expected to be conducted across ten trial sites.
Lawrence Berk, the lead investigator of the Phase IIa trial, said: “Radiation-induced esophagitis is a common, debilitating side effect that can delay or prevent curative cancer treatment, and no FDA-approved therapies to treat it currently exist.
“The initiation of this trial is a critical step toward addressing this urgent unmet need for a treatment option.”
GC4419 is a highly selective small molecule superoxide dismutase (SOD) mimetic designed to protect normal tissues from radiation-induced damages.
Initially, the candidate is developed to treat radiation-induced severe oral mucositis (SOM), for which it has received US Food and Drug Administration (FDA) Fast Track and Breakthrough Therapy designation.
Galera president and CEO Mel Sorensen said: “This trial will broaden our understanding of the utility of avasopasem manganese in the treatment of radiotherapy toxicities beyond our first indication, radiation-induced severe oral mucositis in patients with head and neck cancer.”
GC4419 is also being studied to identify the effectiveness of avasopasem manganese in patients with locally advanced head and neck cancer and radiation-induced OM.