Galera Therapeutics Announces Avasopasem Manganese Improved Markers of Chronic Kidney Disease in Patients Receiving Cisplatin - Seite 2

Specifically, treatment with 90 mg avasopasem demonstrated statistically significant improvements (p<0.05) in return of kidney function to normal ranges after chemoradiotherapy, as measured by serum creatinine (sCr) levels between three and 24 months, estimated glomerular filtration rate (eGFR) between three and 24 months, and blood urea nitrogen (BUN) levels at three, six and 18 months, compared to placebo. A significant reduction (p<0.05) in the incidence of CKD at 12 months (GFR categories G3a-G5), compared to placebo, was also observed.

“This new analysis demonstrating an improvement in markers of kidney function following cisplatin therapy further strengthens the body of evidence for the potential of avasopasem to be an important part of the treatment armamentarium for cancer,” said Mel Sorensen, M.D., President and CEO of Galera. “We look forward to the continued evaluation of the potential of avasopasem in the reduction of chemoradiation-induced toxicities in our ongoing Phase 3 ROMAN trial for the treatment of SOM in head and neck cancer and our Phase 2a trial for the treatment of esophagitis in lung cancer.”

About Avasopasem Manganese (GC4419)

Galera’s lead product candidate, avasopasem manganese (GC4419), is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy.

Avasopasem manganese is currently being studied in the ROMAN trial, a randomized, double blind, placebo-controlled Phase 3 trial of approximately 450 patients (NCT03689712 available at clinicaltrials.gov) to investigate the effects of avasopasem manganese on radiation-induced OM in patients with head and neck cancer. In Galera’s 223-patient, double-blind, randomized, placebo-controlled Phase 2b trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem manganese produced a statistically significant reduction in duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm. Avasopasem manganese also demonstrated clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg treatment arm. No significant safety signals were observed, demonstrating avasopasem manganese was well tolerated when added to a standard radiotherapy regimen. The two-year tumor outcomes follow-up of patients enrolled in the trial were consistent with expectations for intensity-modulated radiation therapy (IMRT)/cisplatin alone suggesting that radiation efficacy was maintained.