Foresee Pharmaceuticals Co., Ltd., today 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. The Phase 2 part will be conducted in the United States. Approximately 99 patients (18-65 years) with a diagnosis of severe to critical COVID 19 with associated ARDS will be randomized in a 1:1:1 ratio to receive FP-025 100 mg, FP-025 300 mg, or placebo twice daily for 28 days. The primary outcome measures of the trial include the proportion of patients alive and not requiring non-invasive or invasive ventilation at Day 28. An interim analysis is planned at the end of Phase 2 trial, of which the efficacy results are expected in the fourth quarter of 2021.

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. 

About FP-025

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.

FP–025 was shown to have effects in preclinical inflammation and fibrosis models, and is safe and efficacious in preclinical and clinical studies. FP-025 is currently being given at 400 mg BID for 12 days in a clinical study of patients with asthma; the study is ongoing and remains blinded. 

About Foresee Pharmaceuticals Co. Ltd.

Foresee is a Taiwan, China Region of China and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.

Foresee's product portfolio includes late stage and early stage programs. FP-001 – stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia. FP-004 – a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain.