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KIT2014

KIT2014

KIT2014 is a novel inhaled cell-permeable peptide designed to modulate intracellular cAMP signaling through disruption of the PI3Kγ-PKA-PDE3/4 complex. By interfering with the scaffold function of PI3Kγ, KIT2014 enhances localized cAMP responses in the lungs, resulting in dual inhibition of PDE3/4 leading to bronchodilation, anti-inflammatory, enhancing of mucociliary clearance, and slowing progression of fibrosis.

Unlike conventional direct PDE inhibitors, KIT2014 acts upstream by modulating the activation of PDE3 and PDE4 within disease-relevant signaling complexes, enabling compartmentalized cAMP elevation across multiple airway cell types, including epithelial cells, smooth muscle cells, immune cells, and fibroblasts.

Preclinical studies have demonstrated that KIT2014 improves airway relaxation, enhances mucociliary function, and modulates epithelial ion transport and fibroblast activation, and reduces neutrophilic inflammation across multiple respiratory disease models. The compound has also shown synergistic activity with CFTR modulators and potential applicability in acquired CFTR dysfunction observed in diseases such as chronic obstructive pulmonary disease (COPD).

Kither Biotech has completed a first-in-human Phase 1 study of inhaled KIT2014 in healthy volunteers, demonstrating favorable safety, tolerability, with negligible systemic exposure. The company is currently advancing KIT2014 toward Phase 2 clinical development in COPD while planning for additional respiratory indications including non-cystic fibrosis bronchiectasis (NCFBE), idiopathic pulmonary fibrosis (IPF), and cystic fibrosis (CF).

COPD

COPD is a progressive respiratory disease characterized by chronic airway inflammation, airflow limitation, mucus hypersecretion, and structural damage to the lungs. COPD is among the leading causes of morbidity and mortality worldwide and is commonly associated with cigarette smoking, environmental exposures, and recurrent airway injury.

Despite the availability of bronchodilators, corticosteroids, and combination therapies, many patients continue to experience persistent symptoms, recurrent exacerbations, and progressive deterioration. Furthermore, the ongoing unmet medical need is underpinned by chronic neutrophilic inflammation and mucus dysfunction, both of which remain insufficiently addressed by currently available therapies.

KIT2014 is initially being developed as an inhaled therapy for COPD, based on its potential to simultaneously target several key drivers of the disease, including bronchoconstriction, impaired mucociliary clearance, and epithelial dysfunction, and airway inflammation through localized modulation of intracellular cAMP signaling in the lungs.

Additional indications include NCFBE, CF, CRS, neutrophilic asthma, and other chronic respiratory disorders with common underlying pathology such as persistent airway inflammation and mucus dysfunction. Although these diseases arise from different underlying causes, they share several pathological features, including dysregulated inflammatory signaling, impaired mucociliary clearance, airway hyperresponsiveness, bronchoconstriction, and structural damage to the respiratory tract.

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PIPELINE

Program

Indication

Mode of Therapy
Proof of Concept
EIH Enabling
Phase 1 Trial
Phase 1/2a
clinical trial

Respiratory indications (COPD, IPF, CF, NCFBE, CRS, etc.)

Add-on to SoC / Monotherapy

Monotherapy

Respiratory indications

Monotherapy

Pulmonary Fibrosis and additional indications

Monotherapy