Phase 1 study supports further development of inhaled respiratory therapy

pharmafile | June 25, 2026 | News story | Research and Development Kither Biotech, respiratory therapy 

Kither Biotech has reported positive results from a phase 1 study of KIT2014, an investigational inhaled therapy being developed for chronic obstructive pulmonary disease (COPD), non-cystic fibrosis bronchiectasis (NCFB) and cystic fibrosis (CF).

The first-in-human trial evaluated the safety, tolerability and pharmacokinetics of KIT2014 in 56 healthy participants.

According to the company, the therapy was safe and well tolerated across all dose levels tested, ranging from 0.1mg to 2mg daily for up to seven days. Researchers also reported that blood plasma levels remained below the limit of detection, suggesting minimal systemic exposure following inhalation.

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KIT2014 is a peptide therapy designed to increase local levels of cyclic adenosine monophosphate (cAMP) in the lungs through dual inhibition of enzymes phosphodiesterase 3 and 4 (PDE3/4). The approach is intended to provide both bronchodilatory and anti-inflammatory effects.

Dimitrios Goundis, CEO of Kither Biotech, said: “We are pleased to report the successful completion of this first-in-human phase 1 study with KIT2014, a significant milestone for Kither Biotech.”

“The study results demonstrate KIT2014’s favourable safety and tolerability profile.”

He added that the therapy’s mechanism of action offered the potential for multiple therapeutic benefits in respiratory diseases.

The randomised, double-blind, placebo-controlled study included both single ascending dose and multiple ascending dose components.

Anita van der Meer, Director of Kither Biotec, said the findings provided a strong foundation for future patient studies in COPD and supported continued clinical development of the programme.

COPD, NCFB and CF are chronic respiratory conditions associated with inflammation, airway obstruction and reduced quality of life. Kither said it now plans to advance KIT2014 into patient studies to further evaluate its therapeutic potential in these diseases.

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