Foresee Pharmaceuticals (TPEx: 6576) has reported successful preliminary results from its Phase 1 clinical trial of linvemastat (FP-020), an innovative and selective matrix metalloproteinase-12 (MMP-12) inhibitor. Conducted in Australia, the trial aimed to assess the safety, tolerability, and pharmacokinetics (PK) of ascending doses of linvemastat in healthy volunteers. The study marks a significant milestone in the development of this promising therapeutic option.

The Phase 1 trial comprised two parts: a Single Ascending Dose (SAD) study with 40 participants, and a Multiple Ascending Dose (MAD) study involving 24 subjects who received daily doses for 10 days. Both parts tested linvemastat against a placebo. Foresee Pharmaceuticals disclosed that the treatment was well tolerated, with no serious adverse events reported. The most common side effects, mild nausea, and headaches, were temporary and resolved by the end of the study.

Dr. Yisheng Lee, Chief Medical Officer of Foresee Pharmaceuticals, indicated that the favorable safety profile demonstrated by linvemastat supports its therapeutic potential, and further studies will explore dosing options in the upcoming Phase 2 trials. Dr. Wenjin Yang, Chief Scientific Officer, highlighted the drug’s potency and favorable pharmacokinetic properties, positioning it as a candidate for longer-term studies.

The company aims to initiate Phase 2 trials in 2025, focusing on diseases with high unmet medical needs such as asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel diseases (IBD). According to Bassem Elmankabadi, Senior Vice President of Clinical Development, the Phase 2 trials will target these conditions due to MMP-12’s established role in immune pathway modulation and fibrosis.

Dr. Ben Chien, CEO and Chairman of Foresee Pharmaceuticals, emphasized the company’s strategy to develop novel treatments targeting immune-fibrotic diseases. He expressed optimism about linvemastat’s potential to tap into multibillion-dollar markets as a leading product across this therapeutic segment.

Expert Insight: Linvemastat’s Potential Impact

Linvemastat (FP-020) is part of Foresee’s strategy to target respiratory and inflammatory conditions through its selective inhibition of MMP-12, an enzyme linked to immune and fibrotic pathways. As the successor to Foresee’s previous candidate, aderamastat (FP-025), linvemastat demonstrates greater potency and improved selectivity. MMP-12’s involvement in respiratory diseases like asthma and COPD has been confirmed by genetic and human expression data, underscoring the potential of this therapeutic approach.

Linvemastat has already shown efficacy in preclinical studies for respiratory diseases and IBD. Given these results, Foresee’s development pipeline includes plans for Phase 2 trials in severe asthma and IBD, projected to start in 2025. These trials aim to further assess the drug’s ability to modulate immune pathways and reduce fibrosis.

Company Profile and Pipeline Overview

Foresee Pharmaceuticals, a Taiwan and US-based biopharmaceutical entity listed on the Taipei Exchange (TPEx: 6576), specializes in developing innovative therapies for respiratory and inflammatory conditions. Its pipeline includes both early and late-stage programs, such as CAMCEVI® for prostate cancer and central precocious puberty. Additionally, Foresee is advancing a suite of next-generation small-molecule drugs, including linvemastat and mirivadelgat (FP-045), aimed at treating a range of rare diseases and immune-fibrotic conditions.

The company continues to expand its Stabilized Injectable Formulation (SIF) long-acting injectable technology and is developing novel candidates for cardiovascular and metabolic indications. Foresee’s strategic focus on MMP-12 inhibition as a mechanism for addressing severe respiratory and inflammatory diseases reflects its commitment to leveraging advanced biological pathways to meet unmet medical needs.

  CAMCEVI, Dr. Ben Chien, Dr. Wenjin Yang, Dr. Yisheng Lee, Foresee Pharmaceuticals, Linvemastat, Taipei Exchange