• 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)
• KIT2014’s unique mode of action improves respiratory symptoms by promoting bronchodilation and reducing lung inflammation

Kither Biotech Pty Ltd and Kither Biotech srl, a clinical-stage biopharmaceutical group of companies developing innovative therapies for respiratory diseases, announced the successful completion of their Phase 1 clinical study of KIT2014 in healthy participants.

“We are pleased to report the successful completion of this first-in-human Phase 1 study with KIT2014, a significant milestone for Kither Biotech,” said Dr. Dimitrios Goundis, CEO of Kither Biotech. “The study results demonstrate KIT2014’s favourable safety and tolerability profile. The unique ability of KIT2014 to increase cAMP in different airway cell types offers the potential for multiple therapeutic benefits, including bronchodilation and anti-inflammatory effects. We look forward to advancing the clinical development of KIT2014, to assess its therapeutic potential in patients with respiratory diseases including COPD, NCFB and CF.”

“We are delighted that this first-in-human study has successfully demonstrated that inhaled KIT2014 was safe and well tolerated across all dose levels evaluated, with no measurable systemic exposure,” said Anita van der Meer, Director of Kither Biotech Pty Ltd. “These findings support the continued clinical development of KIT2014 and provide a strong foundation for advancing into patient studies in COPD, where we aim to further explore its unique multimodal mechanism of action and potential to address important unmet medical needs.”

KIT2014 is a novel cell-permeable peptide delivered via inhalation, which is designed to address multiple pathological pathways common to a number of major respiratory diseases. The drug, which consists of 42 amino acids, acts to promote bronchodilation and reduce lung inflammation. It does this through balanced dual inhibition of the enzymes phosphodiesterase 3 and 4 (PDE3/4), which increases local concentrations of the key signalling molecule cAMP (cyclic adenosine monophosphate). KIT2014 is being developed for a number of respiratory diseases including COPD, NCFB and CF.

Key findings of the Phase 1 study were that:

• Treatment with KIT2014 at doses ranging from 0.1 mg to 2 mg daily for up to 7 days was safe and well tolerated.
• 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.

This Phase 1 clinical trial was a double-blind, randomised, placebo-controlled, two-part dose escalation study (single ascending dose and multiple ascending dose), conducted in 56 healthy participants. The primary objective was to evaluate the safety and tolerability of KIT2014. The secondary objective was to evaluate blood plasma pharmacokinetics.