Soligenix announced the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), has awarded Soligenix a Phase I Small Business Innovation Research (SBIR) of approximately $150,000 to support the evaluation of SGX942 (dusquetide) in pediatric indications. This award will facilitate the assessment of SGX942 safety in juvenile animals, supporting future studies in pediatric populations, including oral mucositis indications in pediatric patients undergoing stem cell transplants and treatments for head and neck cancer.
Innate Defense Regulators (IDRs) regulate the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing. Dusquetide is Soligenix's lead clinical IDR candidate. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens including both antibiotic sensitive and resistant strains, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- or radiation-therapy. Soligenix has previously reported the results of a Phase 2 clinical study using dusquetide in the treatment of oral mucositis in head and neck cancer (HNC) patients undergoing chemoradiation therapy (CRT). In addition to demonstrating a reduction in the median duration of severe oral mucositis in these patients, dusquetide treatment was also associated with a reduced incidence of reported infections and an increased rate of tumor resolution. A pivotal, Phase 3, multinational study in oral mucositis is currently underway in the US and Europe, with an interim analysis expected in the September 2019 timeframe.
"We are appreciative of the continued support provided by NIDCR for the SGX942 development program," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe this SBIR grant award further validates dusquetide's novel mechanism of action, as well as the positive clinical data generated to date. Oral mucositis remains an extremely debilitating side effect of cancer treatment in both adults and children. This funding will allow us to further evaluate the safety of IDRs in juvenile animals, allowing for the conduct of pediatric clinical studies, and the potential to expand future use in the pediatric patient population.
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic...
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