A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) is causing Galera Therapeutics Inc. to dramatically change course to survive, with the company laying off about 70% of its workforce. That layoff, which will reach across several company departments, is designed to extend the cash runway into the second quarter of 2024. The adjustment comes after Galera expanded its commercial leadership in May to prep for a potential launch of avasopasem before the end of 2023.
The error in phase III data reported in late October that sank Galera Therapeutics Inc.’s stock (NASDAQ:GRTX) has been corrected, prompting share values to nearly double on Dec. 14. The error, according to J. Mel Sorensen, Galera’s president and CEO, had resulted in a false “p” value, leading the company to report the study had failed to achieve statistical significance on its primary endpoint. He called the programming error that caused the confusion “quite subtle.”
Based on positive phase IIb data from 2020 for avasopasem manganese (GC-4419) in treating severe oral mucositis (SOM) in patients with locally advanced head and neck cancer, Galera Therapeutics Inc. had been confident about phase III data for the selective small-molecule dismutase. However, the phase III Roman trial failed to hit its primary endpoint of reduction in the incidence of SOM. Mel Sorensen, Galera’s CEO, expressed his surprise at the results and said the company is evaluating the next steps for the program.
