Turin, Italy -based Kither Biotech says that a Phase 1 clinical study of its KIT2014 inhaled PDE3/4 inhibitor successfully demonstrated that the nebulized formulation was safe and well tolerated, with very limited systemic exposure. The SAD / MAD trial enrolled 56 healthy participants and evaluated daily doses ranging from 0.1 mg to 2 mg daily for up to 7 days.
Kither Biotech CEO Dimitrios Goundis commented, “The study results demonstrate KIT2014’s favorable 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.”
Kither Director Anita van der Meer said, “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. 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.”
Read the Kither Biotech press release
