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Taiwan based Foresee Pharmaceuticals Co., Ltd., has announced the initiation of patient dosing in the Phase 2/3 clinical trial of FP-025, its highly selective oral MMP-12 inhibitor, in adult patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome (ARDS).
Dr. Ben Chien, founder and Chairman of Foresee, said, "We are pleased to begin this Phase 2/3 study of FP-025. FP-025 showed significant therapeutic efficacy in preclinical inflammation and fibrosis models of the lung, suggesting that FP-025 may potentially avert the lung injury and fibrosis caused by COVID–19 infections. We look forward to evaluating the potential of FP-025 in the fight against the pandemic."
The Phase 2/3 trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of FP-025. Based on the primary analysis results from Phase 2, an optimal dose will be selected to carry into Phase 3 of the study. Approximately 300 patients will be randomized in a 1:1 ratio to receive FP–025 or placebo for 28 days.
FP 025 is a selective small-molecule inhibitor of MMP-12. Key functions of MMP-12 include the modulation of numerous components of the extracellular matrix, namely elastin and collagen. MMP-12 also modulates effector proteins and cells, such as the influx of monocytes and macrophages involved in inflammation and fibrosis. MMP-12 is mainly produced and secreted by activated macrophages, as well as by pulmonary epithelial cells and chondrocytes. As such, MMP-12 is implicated in many inflammatory and fibrotic diseases of the lung, and a potential mediator of both inflammatory responses and structural remodeling that can occur in patients with COVID-19 associated respiratory disease.
