Complexa has started the first human clinical trial of CXA-10, for treatment of acute kidney injury related to the administration of contrast imaging agents in high-risk patients.
This Phase I trial has been designed to evaluate the safety and pharmacokinetics of Complexa's lead product candidate CXA-10.
This study, with the use of various biomarkers, will also demonstrate CXA-10's mechanism of action and document target organ engagement that will further illuminate its regulation of critical inflammatory pathways.
Complexa president and CEO Josh Tarnoff noted that the company is pleased to have advanced CXA-10 to a Phase I clinical trial, a significant milestone in the development of this innovative next generation inflammatory and metabolic control technology.
"After more than a decade of studying CXA-10, we believe this compound has the potential to become an important advance in the treatment of kidney injury," Tarnoff said.
According to Complexa, advancement of CXA-10 to human clinical trials follows extensive demonstration of efficacy in multiple preclinical animal models, as well as completion of expanded pharmacokinetic and toxicology assessments.
Using the body's own endogenous signaling pathways, CXA-10 promotes defence and repair responses that can be applied to a number of underserved, life-threatening inflammatory-based diseases.
Complexa identified acute kidney injury as the lead proof-of-technology indication due to the significant unmet need in this patient population.
According to Complexa, the company also continues its work on oral chronic treatments and intends to file an investigational new drug with the US Food and Drug Administration later 2014 for oral administration of CXA-10 in the treatment of chronic kidney disease.
Currently, development programmes in other inflammatory, neurodegenerative and metabolic-related therapeutic categories are also under active evaluation.
Image: Human kidney medical diagram with cross section of the inner organ. Photo: courtesy of FreeDigitalPhotos.net.