This Phase 1 clinical trial, which has been successfully completed, consists of two parts. Part 1 is a SAD study in which 40 subjects were randomized to receive a single oral dose of linvemastat (FP-020) or placebo, followed by Part 2, a MAD study, in which 24 subjects were randomized to receive once daily oral dose of linvemastat (FP-020) or placebo for 10 days.
“The overall safety profile for linvemastat in healthy volunteers is a testament to its potential. It suggests that linvemastat was well tolerated, with no Serious Adverse Events reported. The most common Treatment Emergent Adverse Events (TEAEs) were mild nausea and headache and were recoverable at the end of the study, which further reinforces our confidence in its safety and potential,” said Dr.
“We are delighted to present the preliminary data that underscores the unique product profile of linvemastat, Foresee’s second oral MMP-12 inhibitor in clinical development, and potentially the best-in-class profile in view of its superior potency and pharmacokinetic properties. The data and related PK modeling from the first-in-human study in healthy volunteers support our evaluation of different dosing intervals for daily dose for 16 weeks in our potential upcoming Phase 2 clinical trials,” said Dr. Wenjin Yang, Chief Scientific Officer of Foresee.
“Linvemastat holds great therapeutic potential as a potentially disease-modifying oral therapy in severe asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel diseases (IBD) based on the role of MMP-12 in modulation of immune pathways and fibrosis in human respiratory diseases and IBD, where there remains significant unmet medical needs. We aim to improve patient outcomes in the upcoming Phase 2 studies in both asthma and IBD, with initiation planned in 2025,” said
“Our unwavering efforts underscore Foresee’s commitment to pioneering new respiratory and IBD treatments with new mechanisms to target difficult to treat aspects of the diseases. We are excited about the favorable safety, tolerability, and PK profile of linvemastat, and optimistic about the promise of linvemastat, a unique pipeline-in-a-drug opportunity with the potential to capture multibillion US dollar markets as it becomes an anchor product across the immune-fibrotic disease segment and beyond,” said Dr.
About Linvemastat (FP-020) and MMP-12
Linvemastat (FP-020) is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. Linvemastat (FP-020) is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat (FP-025). It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat (FP-025). Linvemastat (FP-020) has shown a favorable efficacy profile in multiple animal models of respiratory diseases and IBD. 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 (FP-025) 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 as well as correlative human expression data demonstrating a potential role of MMP-12 in disease severity and treatment responses in asthma, COPD, sarcoidosis, and IBD. 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.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a
Foresee’s product portfolio includes late and early-stage programs. CAMCEVI ® 42 mg, for the treatment of advanced prostate cancer, is now approved in the