TURIN, Italy — September 29, 2026
Kither Biotech Pty Ltd and Kither Biotech Srl announced that the first patients have been dosed in a randomized, double-blind, placebo-controlled Phase 1b/2a study of KIT2014 in adults with moderate to severe chronic obstructive pulmonary disease (COPD). KIT2014 is an investigational inhaled, cell-permeable peptide designed to provide balanced dual inhibition of phosphodiesterase 3 and 4 (PDE3/4), with the goal of enhancing bronchodilation and reducing lung inflammation. The multicenter study is being conducted in Australia and will evaluate the candidate’s safety, tolerability and pharmacokinetics, while also exploring early measures of efficacy. Kither expects initial results from the trial in Q1 2027, following earlier Phase 1 testing in healthy participants.
KIT2014 Targets Bronchodilation and Lung Inflammation
KIT2014 is a 42-amino-acid peptide administered directly to the lungs by inhalation, where it is designed to inhibit PDE3 and PDE4 simultaneously. According to Kither, balanced inhibition of these enzymes increases local concentrations of cyclic adenosine monophosphate (cAMP), a signaling molecule involved in airway smooth-muscle relaxation and inflammatory processes. The company is developing KIT2014 for respiratory diseases including COPD, non-cystic fibrosis bronchiectasis, idiopathic pulmonary fibrosis and cystic fibrosis. The Phase 1b/2a COPD study will assess whether the compound’s dual mechanism can translate into measurable changes in lung function and inflammatory biomarkers. As an investigational therapy, however, the clinical efficacy and longer-term safety profile of KIT2014 in COPD have not yet been established
Phase 1b/2a Study Evaluates Safety and Lung Function
The Australian Phase 1b/2a trial is designed as a dose-ranging study with multiple clinical endpoints. Safety and tolerability are the primary objectives, while secondary assessments include pharmacokinetic measurements and lung-function parameters such as peak FEV1 over four hours, FEV1 area under the curve over 12 hours and trough FEV1. Researchers will also examine inflammatory cells and protein biomarkers in induced sputum to assess potential changes in airway inflammation. The trial follows a Phase 1 study in 56 healthy participants, in which daily inhaled doses ranging from 0.1 mg to 2 mg for up to seven days were reported to be safe and well tolerated. Plasma concentrations of KIT2014 remained below the limit of detection across single- and multiple-ascending-dose cohorts, according to Kither, suggesting low systemic exposure following inhaled administration.
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Kither Advances KIT2014 Toward Respiratory Clinical Development
The initiation of patient dosing marks the next clinical development stage for KIT2014, less than three months after Kither reported completion of its Phase 1 healthy-volunteer study. The company is evaluating the peptide as a potential treatment approach across several respiratory diseases, with COPD serving as the current clinical focus. The randomized and placebo-controlled design will allow investigators to characterize dose-related safety, pharmacokinetics and preliminary changes in lung function and inflammatory biomarkers. The program’s next major milestone is the expected Q1 2027 initial readout, which should provide the first patient-level clinical data for KIT2014 in COPD. Further development will depend on the safety, pharmacokinetic and exploratory efficacy findings generated in the ongoing study.
Source :Kither Biotech press release
