お知らせ • Oct 21
Foresee Pharmaceuticals Co., Ltd. Announces on Behalf of Subsidiary, Foresee Pharmaceuticals Australia Pty Ltd, the Preliminary Results from the Linvemastat (Fp-020) Phase 1 Trial
O October 20, 2024, Foresee Pharmaceuticals Co., Ltd. announced on behalf of subsidiary, Foresee Pharmaceuticals Australia Pty Ltd, the preliminary results from the Linvemastat (FP-020) Phase 1 trial. New drug name or code: Linvemastat (FP-020), a matrix metalloproteinase-12 (MMP-12) inhibitor (a follow-on compound of FP-025) Indication: For the treatment of asthma, inflammatory bowel disease and chronic obstructive pulmonary disease (COPD). Planned development stages: Phase 2 clinical trial(s), Phase 3 clinical trial(s), and New Drug Application submission Current development stage: (1) Application submission/approval/disapproval/each of clinical trials (include interim analysis):(A) Clinical Study Design: Protocol Title: A Phase 1, 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 b. Study Purpose: To evaluate the safety, tolerability, and pharmacokinetics of linvemastat (FP-020) in healthy volunteers c. Phase of Clinical Study: Phase 1 clinical trial. d. Investigational product: Linvemastat (FP-020), a matrix metalloproteinase-12 (MMP-12) inhibitor (a follow-on compound of FP-025) e. Indication: Asthma, inflammatory bowel disease and chronic obstructive pulmonary disease. f. Endpoints: Evaluate the safety, tolerability and Pharmacokinetic profile of single and multiple ascending oral doses of linvemastat (FP-020) in healthy subjects g. Number of subjects randomized: A total of 64 healthy volunteers were enrolled in this clinical trial. This Phase 1 clinical trial consists of two parts. Part 1 is a single ascending dose study in which 40 subjects (5 cohorts of 8 subjects each) received a single oral dose of linvemastat (FP-020) or placebo on Day 1 in a 6:2 randomization ratio, followed by Part 2, a multiple ascending dose study, in which 24 subjects (3 cohorts of 8 subjects each) received once daily oral dose of linvemastat (FP-020) or placebo in a 6:2 randomization ratio for 10 days. (B) Primary and secondary endpoints and the statistical results: The study preliminary results demonstrated that linvemastat (FP-020) was generally safe and well tolerated to all the subjects, with no Serious Adverse Events reported. The most common reported Treatment Emergent Adverse Events were nausea and headache and recoverable at the end of the study. Additionally, the preliminary Pharmacokinetic data demonstrated that the once-daily oral dose was able to maintain the required PK exposure in the plasma. The clinical data will be utilized in dose selection and trial design for subsequent Phase 2 studies of linvemastat (FP-020) for the treatment of asthma and IBD. (C) The results of a single clinical trial (including the p value or whether there are statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development. The investors shall be careful in judgement and investment. (3) After obtaining official approval or the results of interim analysis or the clinical trial reaching statistical significance, the future strategy will be: Complete the Clinical Study Report and utilize the clinical data in dose selection and trial design for subsequent Phase 2 studies of linvemastat (FP-020) for the treatment of asthma and IBD. Upcoming development plan: (1) Estimated date of completion: The Phase 2 clinical trials for the treatment of asthma and IBD are expected to be initiated in 2025. Asthma is a chronic respiratory condition characterized by recurrent wheezing, coughing, and breathlessness, which occur in acute events known as exacerbations. There are multiple phenotypes and endotypes of asthma with multiple pathophysiological processes. Endotypes include Type 2 (characterized by high Th2 cell populations), and non-Type 2 (often characterized by low eosinophil counts). Inhaled corticosteroids and long-acting beta-adrenergic agonist combinations have become the baseline standard of care across the disease severity spectrum. It is also expected that ICS/LABA/long-acting muscarinic agonist triple combinations will take-up a larger portion of the severe asthma treatment segment. In the last decade, novel severe asthma biologics (e.g., IL-5, IL4/IL-13, TSLP-1 pathway injectable biologic modulators) have demonstrated significant success as add-ons to the inhaled standard of care. However, there remains a very high unmet need for new mechanisms that can complement current treatments, particularly oral drugs that can improve treatment compliance in the pre-biologic patient segment, where inhaled therapies are well known for their poor patient compliance. Additionally, oral drugs that can provide added benefit in the broader phenotypes and difficult to treat asthma groups, including demonstration of reduction in xacerbations, improvement in lung function, and reduction in corticosteroid use. Building on the success of Foresee's aderamastat (FP-025) Phase 2 proof-of-concept, the MMP-12 translational biology foundations built over the years, and the identification of a unique opportunity in asthma, linvemastat (FP-020) was developed as an ideal candidate for asthma populations. Given the unmet needs, market dynamics, and strong demand for oral drugs with new mechanisms, FP-020 (linvemastat) is expected to reach blockbuster status post-launch.
