Kither Biotech Starts Phase 1 Trial of Inhaled Peptide Therapy KIT2014 for Cystic Fibrosis

Kither Biotech, a clinical-stage biotechnology company specializing in respiratory disease therapies, has commenced a Phase 1 clinical trial for their innovative inhaled peptide therapy, KIT2014. Designed as an add-on treatment for existing Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, KIT2014 aims to enhance CFTR function, act as a bronchodilator, and reduce inflammation, offering renewed hope for patients with Cystic Fibrosis (CF).

Cystic Fibrosis is a severe genetic disorder affecting approximately 130,000 individuals globally. It is characterized by mutations in the CFTR gene, which result in defective chloride ion transport across cell membranes. This defect leads to the accumulation of thick, sticky mucus in the lungs, causing impaired mucociliary clearance, chronic bacterial infections, and persistent inflammation, ultimately leading to progressive lung damage.

While advancements in CFTR modulators have significantly improved the quality of life for CF patients, many still face challenges related to persistent inflammation and recurring infections. These issues continue to adversely affect lung function and overall health. Neutrophil-driven inflammation, particularly associated with high levels of neutrophil elastase, is a significant contributor to lung damage in CF patients. KIT2014 aims to address these persistent issues by serving as an additional therapeutic option that complements existing treatments.

KIT2014 works through several mechanisms of action to target the core issues in CF lung disease. As a peptide-based therapy delivered via inhalation, KIT2014 can directly target the lungs. By inhibiting phosphodiesterase 3/4 (PDE3/4), KIT2014 increases levels of cyclic adenosine monophosphate (cAMP). This biochemical pathway enhances CFTR gating in bronchial epithelial cells, thereby improving chloride ion transport. In parallel, its action on airway smooth muscle cells results in bronchodilation. Furthermore, KIT2014 reduces neutrophil-driven inflammation via PDE3/4 inhibition, reducing neutrophil activation and consequent lung tissue damage.

The Phase 1 clinical study for KIT2014 will evaluate its safety and tolerability in healthy adult volunteers through a double-blind, placebo-controlled design. Following this, the study will assess the pharmacokinetics of the inhaled therapy. This trial marks a crucial milestone for Kither Biotech and the broader CF community, as it seeks to address the remaining unmet medical needs of CF patients.

Dr. Dimitrios Goundis, CEO of Kither Biotech, highlighted the significance of this trial, emphasizing that KIT2014 targets three critical challenges in CF: mucus obstruction, chronic inflammation, and bronchoconstriction. These challenges persist even with the current use of CFTR modulators, making KIT2014 a potentially transformative therapy for improved treatment outcomes.

Kither Biotech’s focus on developing innovative therapies for respiratory diseases is exemplified by their lead program, KIT2014. By addressing multiple pathways involved in CF lung disease, KIT2014 holds promise for significantly improving long-term outcomes for CF patients. The company is committed to enhancing the quality of life for those suffering from severe respiratory conditions through innovative therapeutic solutions.

This trial's initiation represents a forward step not only for Kither Biotech but also for the CF community, as it explores new avenues to combat the debilitating effects of Cystic Fibrosis and improve patient care.