Clinical Trials

* On March 29, 2016, Soligenix announced the publication of data demonstrating the mechanism and broad-spectrum activity of dusquetide in preclinical bacterial infection models. Dusquetide, also known by the research name SGX94, is a novel Innate Defense Regulator (IDR) composed of 5 amino acids and is the active ingredient in the lead IDR drug product, SGX942. Recently, SGX942 demonstrated positive results in a Phase 2 clinical trial of oral mucositis in head and neck cancer patients receiving chemoradiation therapy, not only reducing the duration of severe oral mucositis, but also reducing the incidence of infection as well as potentially enhancing the anti-tumor response. The preclinical results were published online in the Journal of Biotechnology.

As an 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 known as p62, or sequestosome-1, thereby enhancing anti-infective mechanisms of the innate immune system and decreasing the often deleterious inflammatory responses. Because IDRs such as dusquetide target the host innate immune system, and not the bacteria directly, they are effective irrespective of the specific biological characteristics of the bacteria, whether antibiotic sensitive or resistant, gram-positive or gram-negative, intracellular or extracellular. IDRs are also complementary to antibiotics, and may provide an important tool in the fight against antibiotic-resistant and emerging infectious diseases.

Innate immunity is not only triggered by infection, but also by tissue damage. As such, IDRs also provide an ability to modulate inflammatory reactions to tissue damage, such as in the pathogenesis of oral mucositis. In a Phase 2 clinical trial, SGX942, containing dusquetide at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis 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, an increased incidence of “complete response” of tumor at the one month follow-up visit was observed (47% in placebo versus 63% in SGX942 at 1.5 mg/kg). Decreases in infection rate were also observed with SGX942 treatment.

These studies were partially funded with grants from the National Research Council of Canada Industrial Research Assistance Program, agreement #703724, the National Institutes of Allergy and Infectious Diseases Small Business Innovation Research grant # 1R43 AI108175-01A1 and grant # 1R43DE024032-01.