
Linvemastat, a highly potent and selective oral MMP-12 inhibitor under development by Taiwan and U.S.-based company Foresee Pharmaceuticals, has successfully completed a phase 1 clinical trial in Australia.
The company said in a news release that the objective of the study was to evaluate the safety, tolerability and pharmacokinetics of oral ascending doses of linvemastat in healthy subjects. The trial consisted of two parts: a Single Ascending Dose (SAD) study in which 40 subjects were randomized to receive a single oral dose of the drug or a placebo; and a Multiple Ascending Dose (MAD) study in which 24 subjects were randomized to receive a once-daily oral dose of the drug or placebo for 10 days.
Yisheng Lee, MD, PhD, MBA, chief medical officer of Foresee, said in a news release that the company was pleased with the preliminary data from the study.
“The overall safety profile for linvemastat in healthy volunteers is a testament to its potential,” Dr. Lee said. “It suggests that linvemastat was well tolerated, with no serious adverse events reported. The most common treatment emergent adverse events were mild nausea and headache and were recoverable at the end of the study, which further reinforces our confidence in its safety and potential.”
Bassem Elmakabadi, MD, senior vice president of clinical development for Forsee, said the drug has potential use for a variety of treatments.
“Linvemastat holds great therapeutic potential as a potentially disease-modifying oral therapy in severe asthma, COPD and inflammatory bowel diseases based on the role of MMP-12 in modulation of immune pathways and fibrosis in human respiratory diseases and IBD, where there remain significant unmet medical needs,” Dr. Elmakabadi said. “We aim to improve patient outcomes in the upcoming phase 2 studies in both asthma and IBD, with initiation planned in 2025.”