Kither Biotech has announced the initiation of a Phase 1 trial of its KIT2014, an inhaled peptide that the company is developing as a CFTR enhancer for use as an add-on with CFTR modulators for the treatment of cystic fibrosis. The SAD/MAD study is expected to enroll 72 healthy volunteers and will evaluate as many as 6 dose levels of KIT2014 delivered via nebulizer versus placebo in the first part of the trial and up to 3 dose levels versus placebo in the second part.
According to Kither, the inhaled therapy inhibits PDE3/4 and elevates cAMP levels. The company says, “In bronchial epithelial cells, this mechanism enhances CFTR gating and improves chloride ion transport, while in airway smooth muscle cells, it acts as a bronchodilator. Additionally, KIT2014 reduces neutrophil-driven inflammation through PDE3/4 inhibition. Together, these mechanisms position KIT2014 as a promising add-on to existing CFTR modulator therapies.”
Kither Biotech CEO Dimitrios Goundis commented, “The initiation of this Phase 1 study marks a significant step forward for Kither Biotech and the CF community. KIT2014 addresses mucus obstruction, chronic inflammation, and bronchoconstriction — 3 critical challenges that affect CF patients even with current CFTR modulators. We are excited to begin assessing the potential of KIT2014 to improve treatment outcomes.”
In addition to KIT2014, Kither’s pipeline includes KITCL27, an inhaled small molecule PI3K inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF). The company is a 2011 spin off from the University of Turin
Read the Kither Biotech press release.
