Shares of Galera Therapeutics Inc (NASDAQ: GRTX) tanked 73% on Tuesday after the company said its Avasopasem trial did not meet the primary endpoint.
Avasopasem does not ‘significantly’ reduce the incidence of SOM
Galera was running a Phase III trial for Avasopasem Manganese in patients with locally advanced head and neck cancer (HNC) in hopes that it will reduce the incidence of severe oral mucositis (SOM).
This morning, however, CEO Mel Sorensen said results of the trial show Avasopasem to not have a “significant” impact on the incidence of SOM.
While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint.
Last week, Galera appointed two new executives with over 25 years of leadership experience in the biopharmaceutical industry.
Avasopasem is well-tolerated
The trial that included 455 patients in total established Avasopasem as well-tolerated versus the placebo. The Pennsylvania-based firm is continuing to analyze the results, it said in the press release on Tuesday.
The study also showed Avasopasem to be effective in cutting the median duration of SOM by more than 50% and minimizing its severity by 27% compared to the placebo.
Galera recently initiated a Phase IIb trial for GC4711 – another of its dismutase mimetic product candidate – in combination with stereotactic body radiation therapy (SBRT) after promising survival benefits shown in the Phase 1/2 pilot trial.
Shares of the Nasdaq-listed company are now trading at $2.0 versus more than $12 in early February.
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