Kither Biotech Announces Publication of New Data in Science Translational Medicine

  • Kither Biotech Announces Publication of New Data in Science Translational Medicine
  • Data supports the use of Kither Biotech’s lead asset, KIT2014, in obstructive airway diseases
  • KIT2014 demonstrated a triple mechanism of action to reverse disease pathogenesis: improving CFTR channel functionality and reducing bronchoconstriction and inflammation
  • Adds evidence to support the use of KIT2014 as a potential complementary therapy to the current standard of care in cystic fibrosis

Torino, Italy,312022Kither biotechnologies (Kither or “the Company”)a biopharmaceutical company developing new therapies for rare respiratory diseases, today announced the publication of a study in Science Translational Medicine describing the mechanism of action of its main asset, KIT2014, and proof-of-concept data for its use in the treatment of chronic obstructive airway diseases (Sci. Transl. Med., 14 (638), eabl6328. • DOI : 10.1126/scitranslmed.abl6328).

KIT2014 is a novel cell-permeable peptide currently being investigated for the treatment of cystic fibrosis (CF) that acts to modulate cyclic adenosine monophosphate (cAMP) levels inside cells. Increasing cAMP can reduce mucus buildup, inflammation and bronchoconstriction, problems inherent in cystic fibrosis. KIT2014 is currently being developed as an adjunct to the current standard of care to improve efficiency by directly focusing on the most important conditions of CF patients, delivered directly into the lungs as therapy by inhalation. The Company plans to start a Phase 1/2A clinical trial of KIT2014 in 2023.

The data demonstrates the therapeutic potential of inhaled KIT2014 (referred to as PI3Kγ MP in the publication) to increase cAMP levels in lung cells, attenuating the pathogenesis of several obstructive airway diseases, such as cystic fibrosis, asthma and COPD, through a triple mechanism of action: promoting bronchodilation, reducing lung inflammation and enhancing the activity of the cystic fibrosis transmembrane conductance regulator (CFTR), the channel that triggers hydration and mucus clearance . In cells from the airways of patients with cystic fibrosis, a disease where CFTR dysfunction is particularly critical, KIT2014 has been reported to increase the effects of existing CFTR modulators by up to 80%.

Vincent Metzler, CEO of Kither Biotech, commented : the publication of theseData in a major peer-reviewed journal represents an important step as we go the development of KIT2014for the treatment of cystic fibrosis as an add-on therapy to CFTR modulators.We are preparingfor our Phase 1/2A clinical testof KIT2014, aswe move one to get close to potentially bringing this innovative treatment for patients with unmet needs.

Alessandra Ghigo, sscientist vsco-founder of Kither Biotech and principal investigator, knowD: these New Data to validateandKIT2014it’s capacityfor modulate cAMP signal transductionin the lungs, increasesing the Functionality CFTR channels, as well as reduceing inflammation and bronchoconstriction, properties that are potentially very beneficialfor sick with cystic fibrosis and other diseases like COPD and asthma. We are I can not wait tostart of clinical trials for KIT2014.”

Emilio Hirsch, sscientist vsco-founder of Kither Biotech and last authorizationr, added: Our KIT2014 data showing an 80% improvement in the effect of existing CFTR modulators demonstrates the potential for this peptidewhenadministered as inhalation therapy, to improve the condition of many patients still suffering from cystic fibrosis or other respiratory diseases.


On Kither Biotech
Kither Biotech is a biopharmaceutical company founded by Professor Alessandra Ghigo, Professor Emilio Hirsch, Professor Alberto Bardelli and Marco Kevin Malisani. The company aims to identify and develop new drug candidates for the treatment of rare lung diseases, with a particular focus on cystic fibrosis and idiopathic pulmonary fibrosis. Kither Biotech is a spin-off from the University of Turin and actively collaborates with the Molecular Biotechnology Center (University of Turin) and other research centers around the world. The company has developed a pipeline of treatments currently in preclinical development, with programs in cystic fibrosis, idiopathic pulmonary fibrosis and other respiratory diseases. |

About KIT2014

KIT2014 is a cell-permeable cAMP modulator peptide that disrupts the interaction of PI3Kgamma with its partner, protein kinase A (PKA), leading to inhibition of phosphodiesterase type 3 and 4 (PDE3/4) and, to in turn, to enhanced cAMP responses in the cell. KIT2014 is currently being investigated for the treatment of cystic fibrosis (CF) as an adjunct inhalation therapy to the current standard of care, providing improved efficacy by having a direct impact on mucus hypersecretion, inflammation of the respiratory tract and bronchoconstriction, the most important conditions of patients with cystic fibrosis. When inhaled, KIT2014 increases cAMP locally in bronchial epithelial cells to promote the opening of CFTR chloride channels, which are essential for mucus hydration, while in lung smooth muscle and immune cells, elevated cAMP limits bronchoconstriction and neutrophil infiltration. In patients with cystic fibrosis, treatment with KIT2014 is believed to restore the function of CFTR mutants by potentiating the effects of CFTR modulators (Ghigo et al., Science Translational Medicine, in press).

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