Filament BioSolutions, a development-stage company focused on delivering innovative therapeutics for nutritional deficiencies, announced 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 high-quality 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 United States 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 Dr. Thomas Cirrito, Co-Founder and CEO of 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.”
Mr. Tatsuya Sato, CEO and President of Ajinomoto Health & Nutrition North America, Inc. remarked, “We are excited to continue to move our collaboration with Filament forward. Filament has an innovative approach to translate our high-quality amino acids into therapies for nutritional and metabolic deficiencies. We look forward to working with Filament to build a portfolio of products that address unmet medical needs for patients.”