To The Moon

$Galera Therapeutics, Inc.(GRTX)$

At that time, Galera CEO Dr. Mel Sorenson said the company was surprised by the results because of the more positive data produced in the early studies. A phase 3 clinical trial, which measures the safety and effectiveness of an experimental treatment in a large patient population, is typically the last hurdle a company must successfully clear before seeking approval for a new drug candidate.

The company said Tuesday that upon further analysis an error by the contract research organization hired for the study was identified in the statistical program. The correction of the error yielded the positive results. Those findings include:

A 16% relative reduction in the incidence of severe oral mucositis in the avasopasem treatment group (54%) versus the placebo group (64%);

A 56% relative reduction in the number of days of severe oral mucositis in the avasopasem treatment group (eight days) vs. placebo group (18 days) ; and

A 27% relative reduction in the severity of severe oral mucositis in the avasopasem treatment group (24%) vs. placebo group (33%).

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Oral mucositis, which causes tissue swelling in the mouth that makes it difficult to swallow and talk, is a potential side effect of radiation therapy and chemotherapy.

“Given the high unmet medical need for patients with head and neck cancer who develop radiotherapy-induced severe oral mucositis, we are gratified that the phase 3 trial achieved statistical significance on the primary endpoint after the correction of the statistical programming error,” Sorensen said on Tuesday.

Sorenson said the company's next steps will be to continue to analyze the full data set from the study, and to meet with the Food and Drug Administration early next year to discuss whether the results from the company's single phase 3 trial — together with its earlier phase 2b trial — could support a new drug application submission.