Kither Biotech Initiates Phase 1b/2a Study of KIT2014 for COPD

TURIN, Italy, Sept. 29, 2026 /CourierPR/ -- Kither Biotech, a clinical-stage biopharmaceutical company based in Australia, has initiated dosing of patients in a Phase 1b/2a clinical study of its novel inhaled peptide therapy, KIT2014, for chronic obstructive pulmonary disease (COPD). The study, which will evaluate the safety, tolerability, and pharmacokinetics of KIT2014, is expected to yield initial results by the first quarter of 2027.

KIT2014 is a proprietary cell-permeable peptide consisting of 42 amino acids. It acts by enhancing bronchodilation and reducing lung inflammation through balanced dual inhibition of phosphodiesterase 3 and 4 (PDE3/4) enzymes. This dual inhibition increases local concentrations of the key signalling molecule cyclic adenosine monophosphate (cAMP), which is crucial for improving airway function.

The multicentre study, conducted at multiple sites in Australia, will also explore early signs of efficacy. Key secondary endpoints include lung function (measured by peak forced expiratory volume in one second (FEV1) over four hours, area under the curve (AUC) over 12 hours, and trough FEV1) and changes in inflammatory cells and protein biomarkers in induced sputum to investigate lung inflammation.

COPD affects more than 400 million people globally and continues to be the third largest cause of death worldwide. It is an irreversible airflow-limiting disease primarily caused by smoking and environmental exposures, characterized by chronic respiratory symptoms and progressive decline in lung function. The underlying pathology is driven by inflammation leading to small airway remodelling and parenchymal destruction.

Non-CF bronchiectasis (NCFB) impacts approximately 500,000 people in the US and a similar number in Europe, with limited treatment options available. It is a chronic airway disease characterized by permanent dilation of the bronchi, leading to cough, sputum production, and recurrent infective exacerbations. The disease creates a vicious cycle of mucus accumulation, infection, and neutrophilic inflammation.

Idiopathic pulmonary fibrosis (IPF) affects approximately three million people worldwide and is a chronic and debilitating disease characterized by scarring (fibrosis) of the tissue surrounding lung alveoli, the small air sacs at the ends of the lungs' bronchioles. IPF is a progressive disease which causes a dry, persistent cough, fatigue, and increasing breathlessness. It can also lead to pulmonary hypertension and heart failure. Prognosis is poor, with around half of patients dying within three years of diagnosis. Most currently available treatments aim to address symptoms, to ease breathing, but do not target the underlying pathology.

Cystic fibrosis (CF) affects approximately 130,000 people worldwide and, despite advances in CFTR modulators, many patients continue to experience persistent inflammation and recurrent infections. It is a life-limiting genetic disease caused by mutations in the CFTR gene, leading to defective chloride ion transport in multiple organ systems. In the lungs, this results in thick, sticky mucus buildup promoting chronic bacterial infections, persistent inflammation, and decline in lung function.