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Entero - Model FW-ICI-AC - Grades 1 and 2 Immune Checkpoint Inhibitor-Associated Colitis
FW-ICI-AC is a niclosamide-based, oral, small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor (ICI)-associated colitis and diarrhea in metastatic cancer patients. The PASSPORT clinical trial, a Phase 2a study to determine the safety and potential efficacy of niclosamide in the treatment of ICI-AC, received FDA IND clearance in Q4 2021.
Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs was over $22 billion in 2019 and growing rapidly.
The incidence of immune-mediated colitis (IMC) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination. Up to 30% of ICI patients develop diarrhea, which can progress to colitis. For example, between 25% and 30% of patients taking ipilimumab (Yervoy) developed diarrhea and roughly 8% to 12% developed colitis.
FW-ICI-AC has the potential to safely treat Grade 1 and Grade 2 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable advanced oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption.
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.