TRK-250 / Toray, BONAC Corp - LARVOL DELTA

A Phase I Study of TRK-250, a Novel siRNA-Based Oligonucleotide, in Patients with Idiopathic Pulmonary Fibrosis. (PubMed, J Aerosol Med Pulm Drug Deliv) - P1 | "Furthermore, TRK-250 was not detected in the systemic circulation following inhalation, indicating low or virtually nonexistent systemic exposure. This study is registered at ClinicalTrials.gov with identifier number NCT03727802."

Journal • P1 data • Fibrosis • Hematological Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • TGFB1

A Phase I Study (Safety, Tolerability, and Pharmacokinetic Study) of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (ATS 2023) - P1 | "Both single doses of TRK-250 from 2 to 60 mg and multiple doses of TRK‑250 from 10 to 60 mg weekly for 4 weeks were safe and well tolerated in this first patient study of IPF. In addition, TRK-250 could not be detected in the systemic circulation following inhalation, indicating low or virtually non-existent systemic exposure and systemic side effects are expected to be low."

Clinical • P1 data • PK/PD data • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • TGFB1

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Toray Industries, Inc | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: Toray Industries, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Toray Industries, Inc; Trial primary completion date: Oct 2021 ➔ Feb 2022

Clinical • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Oligonucleotide Therapeutics PK-7010 in Combination with Nintedanib Ameliorates Bleomycin-Induced Pulmonary Fibrosis in Mice (ATS 2021) - "TRK-250 targeting human TGF-β1 has received much attention as a novel treatment for idiopathic pulmonary fibrosis. PK-7010 in combination with nintedanib ameliorated pulmonary fibrosis induced by bleomycin in mice compared with nintedanib monotherapy.[Conclusion] These results suggest that PK-7010 has an inhibitory effect on fibrosis on experimental pulmonary fibrosis in mice. Oligonucleotide therapeutics for TGF-b1 may be a potential therapeutic agent for pulmonary fibrosis, and may provide additional effects when used in combination with nintedanib."

Combination therapy • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases • TGFB1

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Toray Industries, Inc; Trial completion date: Dec 2021 ➔ Apr 2022; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Toray Industries, Inc; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Toray Industries, Inc; Trial completion date: Oct 2020 ➔ Apr 2021; Trial primary completion date: Jun 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Toray Industries, Inc; Trial completion date: Mar 2020 ➔ Oct 2020; Trial primary completion date: Dec 2019 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date

Inhalation Toxicity of a Novel siRNA-Based Oligonucleotide, TRK-250 in Cynomolgus Monkeys (ATS 2019) - "A novel siRNA-based oligonucleotide, TRK-250, was well tolerated by inhalation in monkeys. There were some histopathological adverse findings in respiratory tract and tracheobronchial lymph nodes; However, the test-areticle related findings were not considered class effects by oligonucleotides nor TGF-β1-related responses but non-specific adaptive changes to inhaled irritant materials and manageable in IPF patients with adequate informed consent."

A Novel siRNA-Based Oligonucleotide, TRK-250, and Its Efficacy for Treatment of Idiopathic Pulmonary Fibrosis (IPF) (ATS 2019) - "A novel siRNA-based oligonucleotide, TRK-250, had a potency to prevent the progression of pulmonary fibrosis."

Clinical

Cellular Uptake of a Novel siRNA-Based Oligonucleotide, TRK-250 in Lung Cells (ATS 2019) - "A novel siRNA-based oligonucleotide, TRK-250 was incorporated into the RISC in lung cells, and the cells took up TRK-250 might be epithelial cells, fibroblasts and macrophages in the lungs."