Soligenix has obtained clearance from the US Food and Drug Administration (FDA) to initiate a Phase III clinical trial of SGX942 (dusquetide) to treat oral mucositis caused in head and neck cancer (HNC) patients who are receiving chemoradiation (CRT).
Dusquetide is an innate defence regulator (IDR) with a mechanism to modulate the immune system's reaction to injury and infection towards an anti-inflammatory and an anti-infective response.
The double-blind, randomised, placebo-controlled, multi-national Phase III trial will evaluate 1.5mg/kg of SGX942 twice a week in 190 patients with squamous cell carcinoma of the oral cavity and oropharynx.
The trial will recruit patients receiving a minimum total cumulative radiation dose of 55Gy, alongside the 80mg-100mg/m² dose of cisplatin chemotherapy every third week.
The trial's primary endpoint is the median duration of severe oral mucositis evaluated through oral examination.
Soligenix president and CEO Christopher Schaber said: "We are pleased to have a pivotal Phase III study design that incorporates feedback from both the FDA and EMA, and that has the potential to support marketing approval in both the US and the European Union.
"Study initiation later this year will represent a significant step forward in our oral mucositis development programme."
The trial is based on the positive findings from the Phase II trial performed in 111 oral mucositis patients on CRT therapy for HNC.
In comparison to placebo, the product was found to decrease the duration of severe oral mucositis by 50%, improve tumour response to CRT, and reduce the rate of mortality and infection.
The data from pre-clinical studies confirmed the efficacy and safety of the product in multiple conditions such as mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.