Biopharmaceutical company Soligenix has reported positive interim results from its Phase II clinical trial of SGX942 (dusquetide) to treat severe oral mucositis.
SGX942 (dusquetide) indicated a statistically reduction in the median duration of severe oral mucositis by 50% in all patients and by 67% in patients with the highest risk for developing severe oral mucositis.
Other key findings in the study included a reduction in the incidence of infection and an increase in tumour resolution at one month post-radiation.
As a first-in-class innate defence regulator (IDR), dusquetide modulates the innate immune system by interacting at an intracellular integration point, operating downstream of most innate immune receptors and upstream of most cytokine and chemokine effectors.
IDRs directly interact with an important protein called p62, or sequestosome-1, which boosts the tissue-healing and anti-infective mechanisms of the innate immune system and decreases the often deleterious inflammatory responses.
The pathogenesis of oral mucositis is believed to be associated with a dysregulation of the innate immune system.
In a randomised, double-blind, placebo-controlled Phase 2 clinical trial, SGX942, containing dusquetide at a dose of 1.5mg/kg, had reduced the median duration of severe oral mucositis when compared to placebo by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer.
In addition to the oral mucositis findings, decreases in the non-fungal infection rate were observed with SGX942 treatment, 45% in placebo versus 28% in SGX942 at 1.5mg/kg.
There was also an increased incidence of complete response of tumour (disappearance) at the one-month follow-up visit – 47% in placebo versus 63% in SGX942 at 1.5mg/kg.
Soligenix senior vice-president and chief scientific officer Oreola Donini said: "The Phase II results not only confirmed that the unique biology of IDRs seen in preclinical animal models translates well into the human clinical setting, but also validated the important role that innate immunity plays in the pathogenesis of oral mucositis.
"With positive proof of concept demonstrated in humans, the IDR technology may now be applied across a range of potential indications, including antibiotic resistant and emerging infectious disease, gastrointestinal inflammation and acute radiation injury."