SNGX - Soligenix's SGX942 flunks oral mucositis study in cancer patients shares plummet 44%

Soligenix (SNGX) plunges 44% premarket in reaction to the announcement of preliminary top-line results for its Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis ((SOM)) in patients with head and neck cancer ((HNC)) receiving chemoradiation.The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo.The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p?0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 group.Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a 50% reduction in the duration of SOM, which decreased from 18 days

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Soligenix's SGX942 flunks oral mucositis study in cancer patients, shares plummet 44%