Foresee Pharmaceuticals has announced that its new drug, the MMP-12 inhibitor linvemastat (FP-020), designed for the treatment of asthma and inflammatory bowel disease, has completed its Phase I clinical trials. This includes both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies aimed at evaluating the safety, tolerability, and pharmacokinetic properties of oral linvemastat (FP-020) in healthy volunteers.
Preliminary results indicate that all participants exhibited good safety and tolerability with linvemastat (FP-020), with no serious adverse events occurring during the trial. The most common treatment-related adverse events (Treatment Emergent Adverse Events, TEAEs) reported were mild nausea and headaches, which resolved after the completion of the trial. Additionally, initial pharmacokinetic analysis suggests that once-daily oral dosing can maintain the required concentration of the drug in the bloodstream. These findings will inform the dose selection and trial design for the subsequent Phase II clinical trials targeting asthma and inflammatory bowel disease.
Dr. Yisheng Lee, Chief Medical Officer of Foresee, stated that the good safety and tolerability profile of linvemastat in healthy participants, along with the absence of serious adverse events, bolsters confidence in its safety and therapeutic potential. The most frequently reported TEAEs were mild nausea and headaches, which resolved post-trial.
Dr. Wen-Jin Yang, Head of R&D, noted that the preliminary clinical data highlights the uniqueness of linvemastat, which is the second MMP-12 inhibitor developed by Foresee. Due to its exceptional activity and pharmacokinetic characteristics, it has the potential to become a best-in-class product. The initial human clinical data and relevant pharmacokinetic models will aid in evaluating the proposed daily dosing frequency over a 16-week treatment period in the upcoming Phase II trials.
Dr. Bassem Elmankabadi, Senior Vice President of Clinical Development, commented that, based on the role of MMP-12 in regulating immune pathways and fibrosis in human respiratory and inflammatory bowel diseases, linvemastat is positioned as an oral medication with the potential for disease modification. It shows significant therapeutic potential for severe asthma, chronic obstructive pulmonary disease, and inflammatory bowel diseases, areas that still have substantial unmet medical needs. The goal is to initiate Phase II clinical trials for asthma and inflammatory bowel disease in 2025 to validate its efficacy.
Resource (mandarin): 逸達治療氣喘及發炎性腸道新藥 一期臨床未發生嚴重副作用
