The first patients have been dosed in a randomized, double-blind, placebo-controlled phase 1b/2a trial for KIT2014, a novel treatment for adults with COPD.
According to a press release, Kither Biotech, the manufacturer of the treatment, is looking to evaluate the safety, tolerability and pharmacokinetics of the inhaled peptide therapy.
The study, “A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD,” is set to be completed by summer 2027.
KIT2014 is a proprietary, cell-permeable peptide consisting of 42 amino acids. It acts to enhance bronchodilation and reduce lung inflammation through balanced dual inhibition of the enzymes phosphodiesterase 3 and 4. The company said this dual inhibition increases local concentrations of the key signaling molecule cyclic adenosine monophosphate (cAMP).
“This dosing comes less than three months after we announced the completion of the phase 1 study in healthy participants,” said Dimitrios Goundis, PhD, CEO of Kither Biotech.
That phase 1 study, “A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects,” reported that treatment with KIT2014 at doses ranging from 0.1 mg to 2 mg daily for up to seven days was safe and well tolerated. Researchers also found that blood plasma levels of patients taking KIT2014 were below the limit of detection at all dose levels, both in the single ascending dose and multiple ascending dose parts of the study. The company said this suggests direct administration to the lungs results in very low systemic exposure.
“We believe KIT2014’s balanced and multimodal mechanism and its consequent bronchodilation and anti-inflammatory effects make it particularly well-suited to this debilitating lung disease, and we look forward to the results of this phase 1b/2a clinical trial,” said Anita van der Meer, director of Kither Biotech.
