Kither Biotech has completed its Phase I clinical trial assessing KIT2014, an inhaled peptide therapy designed for the treatment of respiratory diseases.
The randomised, double-blind, two-part dose-escalation, placebo-controlled trial assessed KIT2014 in 56 healthy participants.
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It involved both single-ascending dose (SAD) and multiple-ascending dose (MAD) components, with a primary aim of evaluating the safety and tolerability of KIT2014 and a secondary aim of monitoring plasma pharmacokinetics.
Participants received daily KIT2014 doses ranging from 0.1mg to 2mg for up to seven days. Results showed that treatment was safe and well tolerated at all doses.
KIT2014 plasma levels remained below the limit of detection across all single-dose and multiple-dose groups. This indicates that inhalation led to low systemic exposure, supporting the therapy’s targeted delivery to the lungs.
Kither Biotech CEO Dr Dimitrios Goundis said: “We are pleased to report the successful completion of this first-in-human Phase I study with KIT014, a significant milestone for Kither Biotech. The study results demonstrate KIT2014’s favourable safety and tolerability profile.”
KIT2014 is a cell-permeable peptide specifically designed for inhalation. It acts by dual inhibition of phosphodiesterases 3 and 4 (PDE3/4), increasing cyclic adenosine monophosphate (cAMP) in airway cells, which can induce bronchodilation and anti-inflammatory responses.
The therapy is under development for chronic obstructive pulmonary disease (COPD), non-cystic fibrosis bronchiectasis (NCFB) and cystic fibrosis (CF).
According to Kither Biotech, inhaled delivery could allow for direct lung targeting and reduced systemic effects, potentially improving safety profiles compared to similar treatments.
