FW-420

FW-420 is a niclosamide-based, locally acting small molecule anti-inflammatory inhibitor therapy being developed by First Wave BioPharma (formerly AzurRx BioPharma) for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in oncology patients receiving immune checkpoint inhibitors. It consists of proprietary formulations of micronized niclosamide designed for minimal systemic absorption, delivered as an oral immediate-release tablet and a topical rectal enema foam, with the aim of achieving high niclosamide concentrations in the gut to inhibit pro‑inflammatory pathways while avoiding systemic immunosuppression.[1][2][3][4][7][9][10][11] FW-420 (later renamed FW-ICI-AC for clinical studies) is being evaluated in early-stage clinical trials (including the PASSPORT Phase 1b/2a–2a program) to determine its safety, tolerability and preliminary efficacy in preventing progression of grade 1–2 ICI-AC and related diarrhea and thereby enabling patients to remain on anticancer immunotherapy.[1][2][3][5][11][12]

Other names

niclosamide-based micronized niclosamide oral immediate-release tablet and rectal enema foam