DOM-Innate Study: Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity
Soligenix has completed recruiting patients into this Phase 3 study with sites in the US and Europe.
A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of SGX942 for the Treatment of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to evaluate the safety and efficacy of SGX942 in reducing the duration of severe oral mucositis associated with chemoradiation therapy in patients receiving these treatments for the treatment of head and neck cancer. Approximately 260 subjects were enrolled in the study.
Topline results: 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 treatment 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 statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial. Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16% in the SGX942 treatment group relative to the placebo group in the per-protocol population.
Learn more about SGX942 trial on ClinicalTrials.gov