NCT07191535

Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)

A Multinational Randomized Double-Blind Placebo-Controlled Phase 2 Study to Evaluate the Effect of Linvemastat (FP-020) in Patients With Partially Controlled Asthma on Inhaled Corticosteroids and Long-Acting Beta-Agonists (syMMPonia Study)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study explores a potential new treatment for adults with moderate-to-severe asthma using a drug called linvemastat, which targets an enzyme linked to lung inflammation. Despite using standard asthma medications, many patients still struggle with symptoms, so researchers are testing whether linvemastat can improve lung function and reduce flare-ups. In a carefully controlled trial, participants receive either one of two doses of the drug or a placebo, while continuing their usual treatments. Over 16 weeks, scientists monitor breathing capacity, symptom control, and safety to determine if linvemastat could offer a meaningful new option for asthma management.

Detailed description

This clinical study investigates the potential of a new drug, linvemastat, to improve outcomes for adults with moderate-to-severe asthma who continue to experience symptoms despite using standard treatments like inhaled corticosteroids and long-acting beta-agonists. Linvemastat works by blocking an enzyme called MMP-12, which is believed to contribute to lung inflammation and tissue damage in asthma. The trial is a Phase 2, randomized, double-blind, placebo-controlled study involving approximately 135 participants across multiple global sites. Participants are assigned to receive either 100 mg or 300 mg of linvemastat, or a placebo, once daily for 16 weeks, while continuing their regular asthma medications. Researchers are primarily measuring changes in lung function, specifically the amount of air a person can forcefully exhale in one second (FEV₁), as well as tracking asthma flare-ups, use of rescue inhalers, and markers of inflammation. Safety is closely monitored through lab tests, heart monitoring, and physical exams. The goal is to determine whether linvemastat can offer a meaningful new option for patients whose asthma remains difficult to control, potentially improving both respiratory health and overall quality of life.

Conditions

• Asthma (Diagnosis)
• Pulmonary Function
• Moderate-to-Severe Asthma

Interventions

Type	Name	Description
DRUG	linvemastat	Matrix Metalloproteinase-12 inhibitor
DRUG	Placebo	Placebo

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-09-01
• First posted: 2025-09-25
• Last updated: 2025-10-20

Regulatory

• FDA-regulated drug study