Filament BioSolutions, a development-stage company focused on delivering therapeutics for nutritional deficiencies, continued progress in the development of its lead product FB-2710, an oral formulation of alanyl-glutamine, for the prevention of radiation-induced oral mucositis in head and neck cancer patients. The company is developing FB-2710 in collaboration with Ajinomoto Co., Inc., a global manufacturer of amino acids for the pharmaceutical and food industry.

Oral mucositis is a debilitating side-effect of high-intensity radiation and chemotherapy. Over 500,000 patients annually in the U.S. experience oral mucositis, including more than 90% of head and neck cancer patients treated with radiation. Oral mucositis results from a breakdown of the epithelial lining in the mouth and can lead to treatment dose reductions, local and systemic infections, compromised nutrition, and hospitalization. As such, oral mucositis is often a dose-limiting toxicity of cancer therapy. There is currently no FDA-approved therapeutic for radiation-induced oral mucositis in head and neck cancer patients.

FB-2710 is designed for optimal bioavailability and cellular uptake of glutamine, a critical nutrient and energy source for rapidly-dividing cells that regenerate the lining of the gastrointestinal tract. During radiation and chemotherapy, glutamine may become conditionally deficient, leaving patients at risk of developing side effects such as oral mucositis. In addition to radiation-induced oral mucositis, Filament plans to conduct preclinical and clinical work with FB-2710 as a co-therapy to commonly prescribed chemotherapies, as well as certain targeted agents. 

“We believe there is a significant opportunity to develop oncology co-therapies that address nutritional and metabolic deficiencies that often confound the underlying disease. These nutritional deficiencies frequently undermine the body’s ability to effectively target the tumor, or contributes to toxicities that limit the effectiveness or intensity of cancer treatment,” said Thomas Cirrito, chief executive officer, Filament BioSolutions. “Radiation-induced oral mucositis is highly debilitating to patients and causes frequent breaks in radiation therapy. Extensive clinical literature, as well as our proprietary preclinical data, validates our approach with FB-2710.”