KIT2014 / Kither Biotech - LARVOL DELTA

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