This Part 1 scientific trial, which has been efficiently accomplished, consists of two components. Half 1 is a SAD examine through which 40 topics had been randomized to obtain a single oral dose of linvemastat (FP-020) or placebo, adopted by Half 2, a MAD examine, through which 24 topics had been randomized to obtain as soon as each day 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,” stated 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,” stated 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,” stated
“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,” stated Dr.
About Linvemastat (FP-020) and MMP-12
Linvemastat (FP-020) is a extremely potent and selective oral MMP-12 inhibitor concentrating on inflammatory and fibrotic ailments. Linvemastat (FP-020) is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat (FP-025). It reveals wonderful pharmaceutical properties, with better efficiency and equally excessive selectivity in comparison with aderamastat (FP-025). Linvemastat (FP-020) has proven a good efficacy profile in a number of animal fashions of respiratory ailments and IBD. MMP-12 performs a task in bronchial asthma pathophysiology and is related to illness severity. A Part 2 allergen problem bronchial asthma proof-of-concept examine in aderamastat (FP-025) has been efficiently accomplished.
The important thing function of MMP-12 in illness is supported by single-nucleotide polymorphisms/genetic proof associated to inflammatory-fibrotic ailments, together with bronchial asthma and COPD in addition to correlative human expression knowledge demonstrating a possible function of MMP-12 in illness severity and therapy responses in bronchial 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 turning into more and more acknowledged as a key marker of inflammatory exacerbations and fibrosis.
About Foresee Prescribed drugs Co., Ltd.
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Foresee’s product portfolio contains late and early-stage packages. CAMCEVI ® 42 mg, for the therapy of superior prostate most cancers, is now permitted within the
