linvemastat (FP-020) / Foresee Pharma, Primevera Therapeutics - LARVOL DELTA

Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Sep 2027 ➔ Sep 2028 | Initiation date: Jan 2026 ➔ Mar 2027 | Trial primary completion date: Jan 2027 ➔ Jan 2028

Trial completion date • Trial initiation date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Foresee Pharmaceuticals announces Global Licensing Agreement for MMP-12 Inhibitors with Primevera Therapeutics LLC (PRNewswire) - "The agreement includes FP-025, FP-020 and third-generation MMP-12 inhibitors currently in the drug discovery stage...In return, Foresee USA will receive an upfront payment of 10 million USD, future potential milestones of up to 574.5 million USD and tiered single-digit percentage royalties...FP-020: Preparing an Investigational New Drug (IND) application for a Phase II clinical trial in asthma, with submission to the U.S. FDA expected in early 2026....FP-025: Preparing for future Phase II clinical trials in rare disease indications."

IND • Licensing / partnership • New P2 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

syMMPonia: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Linvemastat in Patients With Partially Controlled Asthma (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Foresee Pharmaceuticals Announces a Keynote Oral Presentation and Participation at the 2025 American Thoracic Society International Conference (PRNewswire) - "Foresee Pharmaceuticals...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."

Clinical protocol • Asthma

SyMMPonia: a Phase 2 Study of Linvemastat (FP-020) in Uncontrolled Asthma (ATS 2025) - "Sponsored by Foresee Pharmaceuticals Description Speaker: Toby Maher, M.D. Program Title: A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effect of FP-020 (Matrix Metalloproteinase-12 inhibitor) in Patients with Uncontrolled Asthma on Inhaled Corticosteroids (ICS) with Long-Acting Beta Agonist (LABA) as a Standard of Care (syMMPonia Study)"

P2 data • Asthma • Immunology • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed

Trial completion

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Oct 2024

Enrollment open • Trial completion date

Foresee Pharmaceuticals Announces First Subject Dosed in its First-in-Human Clinical Trial of FP-020 (PRNewswire) - "Foresee Pharmaceuticals...announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia...The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-center, single, and multiple ascending oral dose study to evaluate the safety, tolerability, and pharmacokinetics of FP-020 in healthy volunteers. Up to 74 subjects will be enrolled at a site in Australia...'The initiation of this Phase 1 trial underscores our commitment to advancing innovative therapies to benefit patients with severe asthma and COPD.'"

Trial status • Asthma • Chronic Obstructive Pulmonary Disease

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=74 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd.

New P1 trial