KIT2014 / Kither Biotech - LARVOL DELTA

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Kither Biotech Srl | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: Kither Biotech Srl

New P1/2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Compartmentalized PDE3/4 Modulation by Inhaled KIT2014 Improves Airway Epithelial Function and Limits Inflammation in in Non-Cystic Fibrosis Bronchiectasis-relevant models (WBC 2026) - No abstract available

Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Kither Biotech successfully completes Phase 1 clinical trial of KIT2014, a novel inhaled peptide therapy for respiratory diseases (GlobeNewswire) - "First-in-human Phase 1 study in 56 healthy participants demonstrated KIT2014’s safety and tolerability....KIT2014 is being developed as an inhalation therapy for respiratory diseases including chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis (NCFB) and cystic fibrosis (CF)....Key findings of the Phase 1 study were that: (i) Treatment with KIT2014 at doses ranging from 0.1 mg to 2 mg daily for up to 7 days was safe and well tolerated; (ii) 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 direct administration to the lungs results in very low systemic exposure."

First-in-human • P1 data • Trial completion • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

Biophysical and aerodynamic properties of a peptide targeting the A-kinase anchoring function of PI3Kγ for pulmonary cAMP modulation. (PubMed, Sci Rep) - "We previously showed that a cell-permeable PI3Kγ mimetic peptide (PI3Kγ MP, also known as KIT2014) that disrupts the interaction between the AKAP PI3Kγ and PKA enhances β₂-adrenergic receptordriven cAMP signaling to promote airway relaxation, mucus clearance, and reduced inflammation...Aerodynamic profiling further demonstrated mass median aerodynamic diameters suitable for deep lung deposition upon nebulization. Collectively, these results position PI3Kγ MP as a first-in-class disruptor of the PI3Kγ-PKA complex with strong translational potential as an inhaled therapy for obstructive airway diseases driven by cAMP dysregulation."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • PIK3CG

First-in-human Clinical Trial With KIT2014: Safety Assessment of an Inhaled PDE3/4 Inhibitor With Bronchodilator and Anti-inflammatory Effects (ATS 2026) - No abstract available

Clinical • First-in-human • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

KIT2014, a clinical-stage inhaled PDE3/4 inhibitor to target airway neutrophilic inflammation and CFTR dysfunction. (NACFC 2025) - P1 | "KIT2014 effect on CFTR function and stability at the plasma membrane was evaluated in combination with elexacaftor/tezacaftor/ivacaftor (Trikafta). PDE4 inhibitors have shown promise as potent CFTR function inducers in patient-derived intestinal organoids, where residual CFTR function is either present or partially rescued by modulators [3]. KIT2014, a dual PDE3/4 inhibitor, shows unique and broad mechanisms of action to target key pathways underlying CF lung disease in a way that is synergistic to CFTR modulators. KIT2014 was well-tolerated in healthy adults across a range of doses, supporting further clinical evaluation to determine its safety and efficacy in pwCF."

Clinical • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Targeting airway inflammation and dysfunction in non-cystic fibrosis bronchiectasis with KIT2014 inhaled peptide (ERS 2025) - "KIT2014 unique and broad mechanism of action directly targets the pathways underlying Cole's vicious cycle in NCFBE, which could address a critical unmet need as a potential disease-modifying therapy. A Phase 1 clinical trial has been conducted in healthy volunteers, paving the way for further clinical evaluation to determine the safety and efficacy of KIT2014 in NCFBE patients."

Bronchiectasis • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • PIK3CG

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Kither Biotech Srl | Recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Kither Biotech Srl | Trial primary completion date: Mar 2025 ➔ Jun 2025

Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Kither Biotech Srl | Active, not recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Kither Biotech Srl | Recruiting ➔ Active, not recruiting

Enrollment closed • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

KITHER BIOTECH ANNOUNCES PHASE 1 CLINICAL STUDY OF KIT2014, A NOVEL INHALED PEPTIDE THERAPY FOR CYSTIC FIBROSIS (PRNewswire) - "Kither Biotech....today announced the start of a Phase 1 clinical study of KIT2014, a novel inhaled peptide therapy for Cystic Fibrosis (CF). KIT2014 is designed as an add-on therapy to existing CFTR modulators and works by enhancing CFTR gating, promoting bronchodilation, and reducing inflammation through PDE3/4 inhibition."

Trial status • Cystic Fibrosis

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Kither Biotech Srl

New P1 trial • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Kither Biotech announces publication of new data in Science Translational Medicine (BioSpace) - "KIT2014 is a novel, cell-permeable peptide currently being investigated for the treatment of cystic fibrosis (CF) that works to modulate cyclic adenosine monophosphate (cAMP) levels inside cells....The Company expects to begin a Phase 1/2A clinical trial of KIT2014 in 2023."

New P1/2 trial • Cystic Fibrosis

Kither Biotech Raises €18.5 Million Series B and Appoints Dr. Vincent Metzler as Chief Executive Officer (GlobeNewswire) - "Kither Biotech...today announces that it has raised €18.5 million in a Series B financing round and has appointed current Board Member Dr. Vincent Metzler as Chief Executive Officer. Proceeds will be used to fund the clinical development of Kither’s lead product KIT2014, a novel cell-permeable peptide for the treatment of cystic fibrosis (CF)....The Company expects to complete pre-clinical studies in 2022 and begin a Phase 1/2A clinical trial of KIT2014 soon thereafter."

Financing • Preclinical • Cystic Fibrosis

[VIRTUAL] Chemical optimisation of a PI3Kγ competing peptide for the therapy of cystic fibrosis (ECFS 2021) - "Intriguingly, a cell permeable peptide disrupting PI3Kγ-PKA interaction (patent #WO/2016/103176 named KIT2014) increases cAMP in airway smooth muscle and epithelial cells, leading to bronchodilation and CFTR modulation... Overall, these features make the optimised peptide a good candidate to be developed for inhalation therapy of CF lung diseases."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • Targeted Protein Degradation • CFTR • ELANE