• KIT2014 is a novel inhaled peptide therapy being developed for respiratory diseases including chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis (NCFB), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF)
• The first patients have now been dosed in Kither’s randomised, double-blind, placebo-controlled, dose-ranging Phase 1b / 2a trial in adults with moderate to severe COPD
• The Australia-based multicentre study will evaluate the safety, tolerability and pharmacokinetics of KIT2014, plus early signs of efficacy
• KIT2014’s unique and proprietary mode of action, involving balanced dual PDE3/4 inhibition, acts to improve respiratory symptoms by enhancing bronchodilation and reducing lung inflammation
  
  

Kither Biotech Pty Ltd and Kither Biotech Srl, a clinical-stage biopharmaceutical group of companies developing innovative therapies for respiratory diseases, announced that it has dosed the first patients in its Phase 1b / 2a clinical study of KIT2014 in adults with moderate to severe COPD.

Administered by inhalation, KIT2014 is a novel, proprietary cell-permeable peptide, consisting of 42 amino acids, which acts to enhance bronchodilation and reduce lung inflammation through balanced dual inhibition of the enzymes phosphodiesterase 3 and 4 (PDE3/4). This dual inhibition increases local concentrations of the key signalling molecule cAMP (cyclic adenosine monophosphate).

Dr. Dimitrios Goundis, CEO of Kither Biotech, said: “The dosing of patients in Kither’s Phase 1b / 2a study of our novel inhaled peptide KIT2014 in COPD, comes less than three months after we announced the successful completion of the Phase 1 study in healthy participants. This study will investigate the safety, tolerability and pharmacokinetics of KIT2014, as well as early signs of efficacy, in patients with moderate to severe COPD.”

Anita van der Meer, Director of Kither Biotech Pty Ltd, added: “More effective treatments for COPD, which is the third largest cause of morbidity and mortality globally, are desperately needed. We believe KIT2014’s balanced and multimodal mechanism and its consequent bronchodilation and anti-inflammatory effects make it particularly well suited to this debilitating lung disease, and we look forward to the results of this Phase 1b / 2a clinical trial.”

The Phase 1b / 2a study is a randomised, double-blind, placebo-controlled, dose-ranging trial to investigate the safety, tolerability, pharmacokinetics and early efficacy of inhaled KIT2014, taking place at multiple sites in Australia.

The primary focus is the safety and tolerability of inhaled KIT2014. Secondary endpoints include lung function (peak FEV1 over four hours, AUC over 12 hours, and trough FEV1) to assess bronchodilation and pharmacokinetic data. The study will also explore changes in inflammatory cells and protein biomarkers in induced sputum, to investigate changes in lung inflammation. Initial results are expected by Q1 2027.

The start of the Phase 1b / 2a study comes after the successful conclusion of Kither’s double-blind, randomised, placebo-controlled Phase 1 study in 56 healthy participants, which showed inhaled KIT2014 was safe and well tolerated in daily doses ranging from 0.1 mg to 2 mg, in up to 7 days of treatment. It also showed blood plasma levels of KIT2014 were below the limit of detection at all dose levels, both in the single ascending dose (SAD) and multiple ascending dose (MAD) parts of the study, indicating that direct administration to the lungs results in very low systemic exposure.