Neupharma Srl today has announced positive results of its phase 1 pharmacokinetic study with inhaled teicoplanin in cystic fibrosis (CF) patients. Teicoplanin is an antibiotic used in the prophylaxis and treatment of serious infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Methicillin-resistant Staphylococcus aureus (MRSA) is an important emerging pathogen and its detection in the respiratory tract of CF patients is associated with worse survival.
The study was an open-label, mono-centric, single-arm, dose-escalation, cross-over design clinical trial, performed at the “Azienda Ospedaliera Universitaria Integrata” of Verona. A total of 12 patients affected by cystic fibrosis were enrolled.
The goals of the study were the assessment of the bronchial safety and tolerability as well as some key pharmacokinetic parameters of the innovative aerosol formulation of teicoplanin under development at Neupharma in collaboration with Rare Partners Srl Impresa Sociale for the treatment of MRSA infections in CF.
Patients received single administrations of the antibiotic at two different doses, 150 mg and 300 mg, delivered using eFlow® Nebulizer System and a customized handset. Teicoplanin concentration was measured in the blood at different time points for 24 hours after inhalation and in the sputum and the urine for 48 hours after inhalation.
Teicoplanin aerosol administration was well tolerated, and no safety issues were registered. Systemic absorption after inhalation proved to be extremely low showing negligeable drug levels in plasma. Teicoplanin concentration in sputum was dose-dependent and exceeded many folds the MIC value reported for MRSA, assuring a good antibacterial activity covering the 24-hours interval. Drug levels detected at 24 hours demonstrated a prolonged drug clearance from the airways after inhalation with the device under development.
Neupharma is rapidly proceeding towards further development of the product and is planning a phase 2 multicentric, multinational clinical trial in CF patients with MRSA lung infections that should start in first half of 2022.