Inhaled teicoplanin completed phase 1 clinical trial in cystic fibrosis

Neupharma announces the positive conclusion of the phase 1 study, conducted at the “Azienda Ospedaliera Universitaria Integrata” of Verona, with the formulation of inhaled teicoplanin in CF patients.

18 marzo 2021

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.



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