CHF 6333 / Chiesi - LARVOL DELTA

Design, Synthesis, and Biological Evaluation of the Novel Neutrophil Elastase Inhibitor CHF-6333 for the Inhaled Treatment of Bronchiectasis. (PubMed, J Med Chem) - "Salt screening of different counterions, in conjunction with in vivo local irritancy testing, aided in the selection of compound 15-xinafoate (CHF-6333). Efficacy in a lung injury model and no findings in non-GLP toxicity studies promoted CHF-6333 as a clinical candidate."

Journal • Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Jun 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Bronchiectasis • Pulmonary Disease • Respiratory Diseases

HNEi Phase I/IIa Study (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P1/2 trial • Bronchiectasis • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Chiesi Farmaceutici S.p.A.

Clinical • New P1 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases • ELANE

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Trial completion date: Aug 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases • ELANE

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis (clinicaltrials.gov) - P1; N=68; Completed; Sponsor: Chiesi Farmaceutici S.p.A.; Recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases • ELANE