Biopharmaceutical company Foresee Pharmaceuticals Co Ltd announced on Saturday that it started dosing of highly selective oral MMP-12 inhibitor FP-025 in adult patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome (ARDS) in its Phase 2/3 clinical trial.

Under the Phase 2/3 randomized, double-blind, placebo-controlled, multicentre study, the company said it will evaluate the efficacy and safety of FP-025. The Phase 2 part will be conducted in the US. 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 company stated that 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 and the efficacy results are expected in the Q4 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, according to the company.

FP 025 is a selective small molecule inhibitor of MMP-12. 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, concluded the company.