This segment focuses on the research, development, and clinical trials of non-systemic biologics for the treatment of gastrointestinal (GI) diseases. The primary focus is on MS1819, a recombinant lipase designed to treat exocrine pancreatic insufficiency (EPI), a condition where the pancreas does not produce enough enzymes to digest food. Research and development activities include formulation development, preclinical studies, and Phase 2b clinical trials. The company utilizes recombinant protein technology and advanced formulation techniques to improve drug delivery and efficacy. The patient impact is significant, as MS1819 aims to improve the quality of life for patients with EPI by aiding in nutrient absorption. Market positioning is centered on addressing unmet needs in GI disorders, with a competitive advantage in non-systemic, targeted therapies. Future opportunities include expanding the application of MS1819 and developing new therapies for other GI conditions. Regulatory and clinical aspects involve obtaining FDA approval and conducting clinical trials to demonstrate safety and efficacy. Partnerships with contract research organizations (CROs) are utilized to manage clinical trials.

This segment concentrates on the development of proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, for various gastrointestinal indications. The primary focus is on FW-420, designed for grade 1 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients, and FW-1022, targeting COVID-19 gastrointestinal infections. Research and development activities include formulation optimization, preclinical studies, and Phase 2 clinical trials. The company leverages its expertise in drug delivery and formulation to enhance the efficacy and safety of niclosamide. The patient impact is aimed at providing effective treatments for challenging conditions like colitis and COVID-19-related GI issues, improving patient outcomes and quality of life. Market positioning involves targeting unmet needs in oncology and infectious diseases, with a competitive advantage in utilizing a repurposed drug with a novel formulation. Future opportunities include expanding the indications for niclosamide and developing new formulations for other inflammatory conditions. Regulatory and clinical aspects involve obtaining FDA approval and conducting clinical trials to demonstrate safety and efficacy. Partnerships with CROs are utilized to manage clinical trials.