Foresee Pharmaceuticals Reports Positive Phase 1 Results for Linvemastat (FP-020)

Foresee Pharmaceuticals (TPEx: 6576), based in Taipei, recently announced the successful completion of its Phase 1 clinical trial for linvemastat (FP-020), an oral MMP-12 inhibitor. The study, conducted in Australia, aimed to assess the safety, tolerability, and pharmacokinetics of linvemastat in healthy subjects.

The trial consisted of two parts. In Part 1, 40 subjects were given a single dose of linvemastat or a placebo. In Part 2, 24 subjects received daily doses of either linvemastat or a placebo for ten days. The results indicated that linvemastat was well tolerated, with no serious adverse events reported. Mild nausea and headache were the most common side effects, which were resolved by the end of the study.

Dr. Yisheng Lee, Chief Medical Officer at Foresee, highlighted the positive safety profile of linvemastat in healthy volunteers, reinforcing its potential. Dr. Wenjin Yang, Chief Scientific Officer, noted that the preliminary data showcased the unique attributes of linvemastat, marking it as a promising candidate for further development due to its superior potency and pharmacokinetic properties. The data from this first-in-human study supports the evaluation of different dosing intervals for future Phase 2 trials.

Linvemastat shows promise as a disease-modifying oral therapy for severe asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel diseases (IBD), given MMP-12's role in immune pathway modulation and fibrosis in these conditions. Foresee plans to initiate Phase 2 studies in asthma and IBD in 2025, aiming to improve patient outcomes significantly.

Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development at Foresee, emphasized the company’s dedication to pioneering new treatments for respiratory and IBD conditions. The favorable safety, tolerability, and pharmacokinetic profile of linvemastat offer optimism for its potential as an anchor product in the immune-fibrotic disease segment, with the promise of tapping into multibillion-dollar markets.

Linvemastat (FP-020) is a highly selective and potent oral inhibitor of MMP-12, designed to target inflammatory and fibrotic diseases. It follows aderamastat (FP-025), another MMP-12 inhibitor from Foresee, and is distinguished by its greater potency. Linvemastat has demonstrated a favorable efficacy profile in various animal models of respiratory diseases and IBD. MMP-12 is implicated in the pathophysiology of asthma and is linked to disease severity. The role of MMP-12 is supported by genetic evidence and correlative human expression data, highlighting its importance in diseases like asthma, COPD, and IBD.

Foresee Pharmaceuticals, headquartered in Taiwan and the United States, focuses its R&D on two main areas: its Stabilized Injectable Formulation (SIF) technology for long-acting injectables targeting specialty markets, and its innovative preclinical and clinical programs for rare and severe diseases with high unmet needs. Foresee’s product portfolio includes a range of late and early-stage programs. CAMCEVI® 42 mg, for advanced prostate cancer, is approved in multiple regions, with additional indications and regulatory submissions in progress.

Aderamastat (FP-025), another MMP-12 inhibitor, has shown positive outcomes in a Phase 2 asthma study and is being developed for rare immune-fibrotic diseases. Mirivadelgat (FP-045), an ALDH2 activator, is undergoing a Phase 1b/2 study in Fanconi Anemia patients and is planned for a Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) by early 2025. Foresee is also advancing a new candidate from its ALDH2 activator series for metabolic syndrome and broader disease areas.