The study will evaluate the safety and tolerability of an inhaled peptide therapy designed to enhance CFTR function, act as a bronchodilator, and reduce inflammation.
RT’s Three Key Takeaways:
- Phase 1 Trial for KIT2014 Begins: Kither Biotech has initiated a phase 1 clinical study to assess the safety and tolerability of KIT2014, an inhaled peptide therapy designed to support cystic fibrosis (CF) patients as an add-on to current CFTR modulators.
- Multi-Action Mechanism: KIT2014 enhances CFTR function, acts as a bronchodilator, and reduces neutrophil-driven inflammation in CF patients by inhibiting phosphodiesterase 3/4 (PDE3/4), which promotes improved lung function.
- Targeting Persistent CF Challenges: By addressing mucus obstruction, chronic inflammation, and bronchoconstriction, KIT2014 aims to help CF patients who continue to experience lung damage despite advances in CFTR modulator treatments.
Kither Biotech, a clinical-stage biotech company focused on innovative therapies for respiratory diseases, 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 cystic fibrosis transmembrane conductance regulator (CFTR) modulators and works by enhancing CFTR gating, promoting bronchodilation, and reducing inflammation through PDE3/4 inhibition.
“The initiation of this phase 1 study marks a significant step forward for Kither Biotech and the CF community,” says Dimitrios Goundis, PhD, CEO of Kither Biotech, in a release. “KIT2014 addresses mucus obstruction, chronic inflammation, and bronchoconstriction-three critical challenges that affect CF patients even with current CFTR modulators. We are excited to begin assessing the potential of KIT2014 to improve treatment outcomes.”
The KIT2014 Study
This phase 1 double-blind, placebo-controlled study will primarily evaluate the safety and tolerability of single and multiple doses of KIT2014 in healthy adult volunteers, followed by an assessment of pharmacokinetics.
Cystic fibrosis affects approximately 130,000 people worldwide. It is caused by mutations in the CFTR gene, which lead to defective chloride ion transport across cell membranes, resulting in the buildup of thick, sticky mucus in the lungs. This mucus impairs mucociliary clearance, promotes chronic bacterial infections, and triggers persistent inflammation, leading to progressive lung damage.
Unmet Medical Need
Despite significant advances from CFTR modulators, many CF patients continue to experience persistent inflammation and recurring infections, severely impacting lung function and overall health. Neutrophil-driven inflammation, marked by elevated levels of neutrophil elastase, remains a major contributor to lung damage in CF patients.
KIT2014 is being developed to address these issues with a solution that directly targets this inflammation, reduces neutrophil activation, and provides an additional therapeutic benefit that complements existing CF treatments. As a peptide-based therapy, it is designed to target these issues by acting on multiple pathways in CF lung disease.
Delivered through inhalation, it allows direct targeting of the lungs. By inhibiting phosphodiesterase 3/4 (PDE3/4), it elevates cyclic adenosine monophosphate (cAMP) levels. In bronchial epithelial cells, this mechanism enhances CFTR gating and improves chloride ion transport, while in airway smooth muscle cells, it acts as a bronchodilator.
Additionally, KIT2014 reduces neutrophil-driven inflammation through PDE3/4 inhibition. Together, these mechanisms position KIT2014 as a promising add-on to existing CFTR modulator therapies.
