KIT2014 safe, well tolerated in Phase 1 trial of inhaled therapy
Inhaled therapy is being developed for CF, COPD, and NCFB
Written by |
KIT2014, an experimental inhaled therapy by Kither Biotech, was safe and well tolerated in healthy volunteers, according to Phase 1 trial results, potentially supporting further development of the medication for cystic fibrosis (CF) and other lung conditions.
“We are pleased to report the successful completion of this first-in-human Phase 1 study with KIT2014, a significant milestone for Kither Biotech,” Dimitrios Goundis, PhD, CEO of Kither, said in a company press release. “The study results demonstrate KIT2014’s favourable safety and tolerability profile.”
Besides CF, Kither is developing KIT2014 as a potential treatment for people with chronic obstructive pulmonary disease (COPD) and non-CF bronchiectasis (NCFB).
KIT2014 targets airway inflammation, mucus clearance
In CF, genetic mutations result in no or faulty production of the CFTR protein. CFTR typically helps regulate the movement of water and charged particles into and out of cells. Disruptions in CFTR lead the body to make abnormally thick, sticky mucus, which can accumulate in the lungs and other organs, causing symptoms.
CFTR modulators, medications that aim to increase the functionality of the CFTR protein, are a mainstay of CF treatment. However, problems such as inflammation and recurrent infections sometimes remain despite these therapies.
Other lung conditions, including COPD and NCFB, share similar disease processes. COPD is a progressive disease in which airflow through the airways becomes limited. Like CF, NCFB involves buildup of mucus in the lungs. Anti-inflammatory treatments and bronchodilators, which relax muscles around the lungs to widen airways, may help people with these conditions.
Kither designed the therapy to promote balanced inhibition of phosphodiesterase 3 and 4 (PDE3/4), a pair of enzymes that regulate the signaling molecule cyclic adenosine monophosphate (cAMP). Inhibiting PDE3/4 may increase local levels of cAMP, which the company expects will have beneficial effects in the lungs.
“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,” Goundis said.
Preclinical studies have also suggested that KIT2014 can enhance the effects of CFTR modulators.
Phase 1 trial tested inhaled KIT2014 in healthy volunteers
The Phase 1 trial (NCT06659757), which occurred in Australia, was a placebo-controlled study involving 56 healthy participants. Kither said treatment with KIT2014 at doses ranging from 0.1 mg to 2 mg daily for up to seven days was safe and well tolerated. Participants inhaled KIT2014 or placebo using a nebulizer, which turns a liquid medication into a mist.
During the first part of the study, participants received a single dose of KIT2014 or placebo. The second part tested multiple ascending, or increasing, KIT2014 dose levels, with participants receiving KIT2014 or placebo.
Throughout the trial, KIT2014 was safe and well tolerated. “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,” said Anita van der Meer, director of Kither.
In addition to measuring safety, the trial investigators measured levels of KIT2014 in the blood after inhalation treatment. They found no detectable KIT2014 in blood plasma, the liquid component of blood. Low systemic exposure could reduce the risk of side effects or complications.
Following these positive results, Kither plans to continue developing the medication. “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,” Goundis said.
Leave a comment
Fill in the required fields to post. Your email address will not be published.