The National Institutes of Health (NIH) has selected Soligenix’s SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer (HNC) patients as a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Commercialization Accelerator Program Phase II awardee for 2018-2019.
Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity, but by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.
Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.
The SGX942 program has been specifically selected by the NIH for the Commercialization Transition Track, which provides technical assistance to awardee companies to advance NIH-funded technologies towards commercialization and market readiness.
Soligenix applied for the CAP as part of its $1.5 million Phase II SBIR/STTR NIH grant to develop SGX942 as a treatment for oral mucositis in HNC patients receiving chemoradiation therapy (CRT). Only a select number of SBIR Phase II awarded companies are accepted into the CAP by the NIH.
Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted.
Source: Soligenix press release, edited.