Turns out Galera's radiotherapy complication drug did work after all, and investors are thrilled
Galera’s shares were pummeled in the wake of news that its radiotherapy complication drug flunked a phase 3 study, but now the biotech says the study results were in error, and the treatment did, in fact, work.
The small biotech posted an update Tuesday on the phase 3 trial of avasopasem manganese in severe oral mucositis, or SOM. Oral mucositis is a condition in which the epithelial cells lining the gastrointestinal tract break down following radiotherapy treatment, causing an inability to eat solid food or drink liquids in its most serious form.
Previously, Galera said avasopasem failed to reduce incidences of the debilitating condition among patients with locally advanced head and neck cancer during a late-stage trial called ROMAN.
But now, the company says an error made by the contract research organization has been discovered, and the results were actually better than previously thought. In reality, avasopasem achieved a 16% reduction in the incidence of SOM compared to placebo and a 56% relative reduction in the number of days of SOM. Finally, the results show a 27% relative reduction in severity of the condition.
That means avasopasem did meet the primary goal of the trial, according to Galera.
The news sent the company’s shares up 106% to around $2.86 as of 2:10 p.m. ET on Dec. 14, compared to a previous close of $1.38. The trial’s reported failure had kicked Galera’s shares down 70% from $7.50 to $2.29 on Oct. 19.
“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 ROMAN trial achieved statistical significance on the primary endpoint after the correction of the statistical programming error,” Galera President and CEO Mel Sorensen, M.D., said in a statement.
The company also released top-line results from a different phase 2a study called EUSOM being conducted in Europe, which backed up the results of the ROMAN trial.
Galera said it plans to meet with the FDA in 2022 to discuss the results and whether they are solid enough to seek a new drug application. Meanwhile, executives will host an investor call Wednesday morning to discuss the corrected results and provide a business update.