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

NCT07191535 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FP-020C-25-001
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

central spirometry; type-2 (T2) high asthma; asthma management

Outcome Measures

Primary Outcomes (1)

• The mean change in trough FEV1 assessed by central spirometry

  FEV1 (measured in liters by spirometer), and the trough measurement is taken 24 hours after the morning dose on the previous day of the randomized study drug. The Baseline is defined as the last available FEV1 measurement taken prior to the first dose of the randomized study drug.

  Baseline to Week 16

Secondary Outcomes (12)

• Time to first severe asthma exacerbation

  Baseline up to Week 16].

• Change in clinical laboratory testing

  Baseline to Week 16

• FeNO Changes

  Baseline up to Week 16

• Change in Sputum

  Baseline up to Week 16

• Pre-bronchodilator FEV1 changes

  Baseline to Week 16

Study Arms (3)

linvemastat 100 mg once daily

EXPERIMENTAL

linvemastat 100 mg once daily

Drug: linvemastat

linvemastat 300 mg once daily

EXPERIMENTAL

linvemastat 300 mg once daily

Drug: linvemastat

Placebo Comparator

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

linvemastat DRUG

Matrix Metalloproteinase-12 inhibitor

Also known as: FP-020

linvemastat 100 mg once daily; linvemastat 300 mg once daily

Placebo DRUG

Placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 - 85 years at the time of signing informed consent
• Patient is able to provide written informed consent.
• Documented physician´s diagnosis of Type 2 high asthma, as per the Global Initiative for Asthma (GINA) 2023 guideline 2023 at Screening.
• Patients with existing treatment with at least low to medium doses of ICS therapy in combination with LABA as a second controller for at least 90 days and a stable/optimized dose ≥30 days prior to Day 1. Patients on triple therapy with a long-acting muscarinic antagonist (LAMA) will be excluded.
• An ACQ score ≥ 1.5 at Screening.
• Patients with a pre-bronchodilator FEV1 value of 40% to 80% of the patient's predicted value at Screening.
• Patients must have experienced at least once, within 2 years prior to Screening, one of the following asthma exacerbation events: Treatment with a systemic steroid (oral or parenteral) for worsening asthma. Hospitalization or emergency medical care visit for worsening asthma.
• Males with a partner of childbearing potential must use a condom for the duration of study treatment and at least 96 hours after discontinuing the study drug.
• Female patients of childbearing potential (including those \< 1 year post-menopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study and for 30 days after the last dose of study drug. Highly effective contraceptive measures for female patients of childbearing potential include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (when partner is the sole sexual partner of the female patient and when the partner has received medical assessment of the surgical success), sexual abstinence.
• Women not of childbearing potential are defined as: Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening OR Have a congenital or acquired condition that prevents childbearing.

You may not qualify if:

• Pregnant or breastfeeding.
• Current smoker (including vaping) or cessation of smoking within the 6 months prior to Day 1, or \> 10 pack-year history of smoking.
• Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer, prior to randomization.
• Evidence of COVID-19 infection at Screening, as judged by the Investigator.
• Advanced congestive heart failure \[New York Heart Association (NYHA) class 3 or 4\].
• Known hypersensitivity to any component of the formulation of linvemastat or any component of the excipient.
• Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.
• History of solid organ transplant.
• Anti-immunoglobulin E (IgE) therapy \[e.g., omalizumab (Xolair®)\] within 130 days prior to Screening or any other biologic therapy \[including anti-TSLP, anti-IL-4/4R or IL-5/5R monoclonal antibodies (mAb)\] or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 2 months or 5 half-lives prior to Screening, whichever is longer.
• Evidence of active tuberculosis (TB) infection at Screening, as judged by the Investigator.
• Active acute or chronic psychiatric illness that, in the opinion of the Investigator, may prevent from complying with study instructions.
• Known positive history of malignancy within 5 years of Screening (with the exception of basal cell skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy).
• Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) infection at Screening.
• Concurrent emphysema.
• Use of any therapeutics that are strong inhibitors and inducers of CYP3A4 or CYP2C8 \[e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine\].

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• QPS Holdings LLC: collaborator

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bassem Elmankabadi, MD

  Foresee Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Bassem Elmankabadi, MD

CONTACT

+1 562-310-8718; Bassem.elmankabadi@foreseepharma.com

Yisheng Lee

CONTACT

408-823-4807; yisheng.lee@foreseepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study drug will be provided in bottles. Each bottle contains 32 capsules as a 28-day study drug supply. A bottle is intended for one month (28 days) use with 4 extra capsules allowing for the visit windows and flexibility. Each bottle will have a unique number which is assigned to the study patient by the Interactive Response Technology (IRT) system. All study drugs will be dispensed by the Investigator or a person under his/her supervision
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share