Foresee Pharmaceuticals announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-center, single, and multiple ascending oral dose study to evaluate the safety, tolerability, and pharmacokinetics of FP-020 in healthy volunteers. Up to 74 subjects will be enrolled at a site in Australia.

FP-020 is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. FP-020 is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat. It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat.

FP-020 has shown a favorable efficacy profile in multiple animal models of idiopathic pulmonary fibrosis and sarcoidosis. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. A Phase 2 allergen challenge asthma proof-of-concept study in aderamastat has been successfully completed.

The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and is becoming increasingly recognized as a key marker of inflammatory exacerbations and fibrosis.