aderamastat (FP-025) / Foresee Pharma - LARVOL DELTA

Application of bacterial-derived long cellulose nanofiber to suspension culture of mammalian cells as a shear protectant. (PubMed, Int J Biol Macromol) - "The media supplemented with hydroxypropyl cellulose-adsorbed NFBC (HP-NFBC) exhibited an increase in shear viscosity according to rheometric analysis, similar to FP003, a commercially available medium additive...It is suggested that the decline of these parameters in high-viscosity media suppresses the hydrodynamic stress on cells. This study highlights the potential of HP-NFBC as a shear protectant in mammalian cell suspension culture."

Journal

Validation of a method for the determination of Aderamastat (FP-025) in K2EDTA human plasma by LC-MS/MS. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Authors declare that, this novel data is not published and not under consideration for publication by another journal than this journal. All data will be made available on request."

Journal • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Effect of Aderamastat (FP-025), A Selective MMP-12 Inhibitor, on Allergen-induced Airway Responses in Subjects With House-dust Mite Allergic Mild Asthma and Blood Eosinophilia (ATS 2024) - "Based on our preliminary findings, FP-025 shows potential in allergic asthma by attenuation of the sequelae of the LAR. Underlying mechanisms accountable for the observed - potentially long-lasting - efficacy warrant further investigation."

Clinical • Asthma • Eosinophilia • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Effect of MMP-12 inhibitor, Adermastat-(FP-025), on allergen-induced late response in asthmatic subjects (ERS 2023) - "Adermastat-(FP-025) was safe and demonstrated promising results in allergic asthma patients.; Physiology; General respiratory patient care; Cell and molecular biology; Epidemiology"

Clinical • Late-breaking abstract • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Reversible suspension culture of human vascular smooth muscle cells using the functional biopolymer FP003. (PubMed, In Vitro Cell Dev Biol Anim) - "This growth arrest was a reversible property that showed no significant changes in the expressions of the marker proteins α-smooth muscle actin and smooth muscle myosin heavy chain. These results suggest that human SMCs can be stably cultured in suspension with FP003 without losing their characteristics when they are cultured on plastic plates again."

Journal • Eye Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CCND1

Foresee Pharmaceuticals Selected for Late-Breaking Oral Presentation on its Aderamastat Phase 2 Study Results at the European Respiratory Society (ERS) International Congress 2023 (PRNewswire) - "Foresee Pharmaceuticals...announced today that the company has been selected for a late-breaking oral presentation on the positive primary outcomes of its aderamastat (FP-025) Phase 2 proof-of-concept allergic asthma study at the European Respiratory Society (ERS) International Congress 2023 taking place in Milan, Italy from September 9-13, 2023."

P2a data • Asthma • Respiratory Diseases

The Effect of FP-025, a MMP-12 Inhibitor, on Allergen-induced Airway Responses and Airway Inflammation in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma (clinicaltrials.gov) - P2 | N=29 | Completed | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Oct 2022 ➔ Dec 2022

Trial completion • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

"Biological and Medical Stock" Yida's Phase II Clinical Trial for Allergic Asthma Unblinded by the End of March [Google translation] (China Times) - P2 | N=32 | NCT03858686 | Sponsor: Foresee Pharmaceuticals Co., Ltd.| "The clinical trial of Yida (6576) FP-025 for allergic asthma is expected to be unblinded before the end of March, and international authorization will be initiated. Yida conducted a phase II clinical proof of concept of a new ingredient and a new drug MMP-12 inhibitor FP-025 (aderamastat) in the Netherlands for the treatment of allergic asthma. The interim analysis showed that FP-025 was safe and well tolerated. Compared with the control group, there was a positive improvement trend. Currently in the stage of final clinical data collation and statistical analysis, the main analysis results of the trial are expected to be announced before the end of March 2023, after which international authorization negotiations will be initiated."

P2 data • Asthma • Chronic Obstructive Pulmonary Disease

Efficacy of FP-025, a novel Matrix metalloproteinase-12 (MMP-12) inhibitor in murine allergic asthma. (PubMed, Allergy) - No abstract available

Journal • Preclinical • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Suspension culture of human induced pluripotent stem cell-derived intestinal organoids using natural polysaccharides. (PubMed, Biomaterials) - "The observed activities of the drug metabolizing enzymes and drug transporters in the generated HIOs suggested that they have pharmacokinetic functions. We believe that suspension culture of HIOs using FP001 or FP003 can be widely applied to not only drug discovery research but also disease research and regenerative medicine."

Journal

Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Unknown status ➔ Completed

Trial completion

A Phase 2/3, Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2/3 | N=90 | Terminated | Sponsor: Foresee Pharmaceuticals Co., Ltd. | N=403 ➔ 90 | Recruiting ➔ Terminated; Study stopped at interim analysis point, due to lack of study subjects to recruit.

Enrollment change • Trial termination • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

The Effect of FP-025, a MMP-12 Inhibitor, on Allergen-induced Airway Responses and Airway Inflammation in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Dec 2019 ➔ Dec 2022 | Trial primary completion date: Sep 2019 ➔ Oct 2022

Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A miniature dialysis-culture device allows high-density human-induced pluripotent stem cells expansion from growth factor accumulation. (PubMed, Commun Biol) - "The high-density expansion was supported by reduction of excessive shear stress and agglomeration mediated by the addition of the functional polymer FP003...We showed that growth-factor-accumulation dynamics in a low-shear-stress environment successfully improved hiPSC proliferation, pluripotency, and differentiation potential. This miniaturised dialysis-culture system demonstrated the feasibility of cost-effective mass production of hiPSCs in high-density culture."

Journal • FGF2 • TGFB1

A Phase 2/3, Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2/3; N=403; Recruiting; Sponsor: Foresee Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Aug 2022 ➔ Feb 2022

Clinical • Enrollment open • Trial completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • PCR

Foresee Pharmaceuticals Announces Dosing of First Patient in Phase 2/3 Clinical Trial of FP-025 for Treatment of COVID-19 Associated ARDS (PRNewswire) - "Foresee Pharmaceuticals Co., Ltd....announced the initiation of patient dosing in the Phase 2/3 clinical trial of FP-025...The Phase 2 part will be conducted in the United States. Approximately 99 patients...will be randomized in a 1:1:1 ratio to receive FP-025 100 mg, FP-025 300 mg, or placebo twice daily for 28 days....An interim analysis is planned at the end of Phase 2 trial, of which the efficacy results are expected in the fourth quarter of 2021. Based on the primary analysis results from Phase 2, an optimal dose will be selected to carry into Phase 3 of the study. Approximately 300 patients will be randomized in a 1:1 ratio to receive FP–025 or placebo for 28 days."

P2 data • Trial status • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

A Phase 2/3, Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2/3; N=403; Not yet recruiting; Sponsor: Foresee Pharmaceuticals Co., Ltd.

Clinical • New P2/3 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Yida Biotech's new crown new drug is approved by the U.S. FDA to perform Phase II/III clinical trials [Google translation] (money.udn.com) - "Yida Biotechnology...has been notified by the U.S. Food and Drug Administration (FDA) that it has to start the implementation of the new component and new drug FP-025 for acute respiratory distress syndrome (ARDS) phase II/III caused by new coronary pneumonia Clinical trials, the trial will start...and is expected to become the first new drug for ARDS caused by new coronary pneumonia....It is scheduled to make possible trial design adjustments based on the trial data after the Phase II clinical trial is completed...Phase II clinical trial is expected to recruit about 100 subjects in the United States, and the same number of subjects will be randomly assigned to three test groups: FP-025 100 mg orally twice a day, FP-025 300 mg or placebo group."

New P2/3 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. (PubMed, Clin Drug Investig) - P1 | "FP-025 was well tolerated and showed a favorable pharmacokinetic profile following ASD-in-Capsule dosing. Efficacy studies in target patient populations, including asthma, chronic obstructive pulmonary disease (COPD), and pulmonary fibrosis, are warranted."

Clinical • Journal • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

Foresee Pharmaceuticals Announces Completion of US$47 Million Financing (PRNewswire.co.uk) - "Foresee pharmaceuticals...announces that it has successfully completed an underwritten public offering of 15,000,000 shares of its common stock to the public at a price of NT$88 per share. The aggregate gross proceeds to Foresee from the offering were approximately US$47 million...The proceeds of the Public Offering will be used for...supporting Foresee's existing drug research and development programs – such as FP-025, for which a Phase II/III clinical trial IND application was recently submitted to the FDA for the treatment of acute respiratory distress syndrome (ARDS) in COVID-19 patients."

Financing • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Protection of human induced pluripotent stem cells against shear stress in suspension culture by Bingham plastic fluid. (PubMed, Biotechnol Prog) - "Rheometric analysis showed that the culture medium gained yield stress and became a Bingham plastic fluid, after supplementation with the polymer FP003...After the initial aggregation step, whereas strong agitation (120 rpm) of a conventional culture medium resulted in massive cell death, in the Bingham plastic fluid we obtained the same growth as the normal culture with optimal agitation (90 rpm). This indicates that Bingham plastic fluid protected cells from shear stress in suspension culture and could be used to enhance their robustness when developing a large-scale."

Journal