TAIPEI, May 14, 2025 /PRNewswire/ — Foresee Pharmaceuticals (TPEx: 6576) (“Foresee”) announced today that it will actively participate in and Toby Maher, M.D., will deliver a keynote presentation titled “SyMMPonia: A Phase 2 Study of Linvemastat (FP-020) in Uncontrolled Asthma” at the Innovation Theater on May 18, 2025. The session will highlight the design and objectives of the multinational syMMPonia Study, a pivotal clinical trial evaluating the efficacy of Linvemastat (FP-020), a novel Matrix Metalloproteinase-12 (MMP-12) inhibitor, in patients with uncontrolled asthma.
Event Details:
Speaker: Keynote Presentation by Toby Maher, M.D., Ph.D.
Title: SyMMPonia: A Phase 2 Study of Linvemastat (FP-020) in Uncontrolled Asthma
When: May 18, 2025 | 1:30 – 2:00 p.m. Pacific Standard Time
Where: American Thoracic Society Innovation Theater 1, San Francisco, CA
https://ats2025.d365.events/directory/sessions/c082fddd-5c54-47e7-866e-29b26d7eca3e
Dr. Maher, a renowned expert in the pulmonary field, will present details of the syMMPonia Study, a Phase 2, randomized, double-blinded, placebo-controlled clinical trial designed to evaluate the efficacy of Linvemastat (FP-020) compared to placebo in patients with T2-high, moderate-to-severe asthma who remain partially controlled despite standard therapy with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).
The study aims to address unmet needs in asthma management by targeting MMP-12, an enzyme implicated in airway inflammation and remodeling. Attendees will gain insights into the rationale behind targeting MMP-12 in T2-high asthma and the study design, including patient selection and endpoints, and Potential implications for future asthma therapies.
“Targeting MMP12 represents a paradigm shift, by addressing inflammation and remodeling, Linvemastat (FP-020) could redefine long-term outcomes for patients with poorly controlled asthma. Collaborative efforts to validate these results in the syMMPonia Phase 2 trial are essential to demonstrate statistically significant improvements in FEV1 and reductions in exacerbations alongside biomarker evidence of decreased collagen degradation. These findings could underscore the potential of Linvemastat (FP-020) to modify disease trajectories in high-risk patients,” stated Toby Maher, M.D., Ph.D., Professor of Clinical Medicine at Keck School of Medicine, of USC.
“Today’s progress exemplifies our mission to lead through innovation. syMMPonia trial is a testament to our resolve to tackle medicine’s toughest challenges. We are initiating this Phase 2 trial and exploring partnerships in parallel to accelerate patient access worldwide, and we are excited to share our innovation with the clinical community during ATS,” stated Dr. Ben Chien, Ph.D., Chairman and CEO of Foresee Pharmaceuticals
About Linvemastat (FP-020) and MMP-12
Linvemastat (FP-020) is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. Linvemastat (FP-020) is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat (FP-025). It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat (FP-025). Linvemastat (FP-020) has shown a favorable efficacy profile in multiple animal models of respiratory diseases and IBD. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. A Phase 2 allergen challenge asthma proof-of-concept study in aderamastat (FP-025) has been successfully completed.
The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD as well as correlative human expression data demonstrating a potential role of MMP-12 in disease severity and treatment responses in asthma, COPD, sarcoidosis, and IBD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and is becoming increasingly recognized as a key marker of inflammatory exacerbations and fibrosis.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee’s R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.
Foresee’s product portfolio includes late and early-stage programs. CAMCEVI 42 mg, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is on-going. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. www.foreseepharma.com
