New Jersey-based biopharmaceutical company, Soligenix has revealed that its developing drug has showed positive results against oral mucositis in Phase 2 clinical trial.
The drug called SGX942 is a first-in-class innate defense regulator (IDR) which at a dose of 1.5 mg/kg has successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive Chemo-Radiation Therapy (CRT).
‘Soligenix’s drug, SGX942 is a first-in-class innate defense regulator (IDR) that has reduced severe oral mucositis by 67% in patients receiving Chemo-Radiation Therapy (CRT).’
Oral Mucositis is a devastating side effect of CRT, which is used for the treatment of head and neck cancers. Currently, there is no cure for this disease and SGX942 is the first Innate Defense Regulator in development for oral mucositis.
The phase 2 clinical trial was conducted in 111 patients undergoing CRT for head and neck cancer. They were grouped across three SGX942 dose groups and a placebo group. The results were found positive in the 1.5 mg/kg treatment group. The drug reduced the median duration of severe oral mucositis by 50%, from 18 days to nine days.
Patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe oral mucositis of 67%, from 30 days to 10 days.
"We are extremely pleased with the findings from the first Phase 2 study of SGX942. The study met all of its objectives of defining the best dose, the most appropriate clinical endpoint, and patient population to use in future pivotal trials," said Richard Straube, chief medical officer.