Complexa initiates first human clinical trial of CXA-10 in acute kidney injury

The Phase I study is Complexa’s first human clinical trial designed to assess the safety and pharmacokinetics of its CXA-10.

With the use of various biomarkers, this study will also demonstrate CXA-10’s mechanism of action and document target organ engagement that will further illuminate its regulation of critical inflammatory pathways.

Following extensive demonstration of efficacy in multiple preclinical animal models and the completion of expanded pharmacokinetic and toxicology assessments, Complexa has advanced CXA-10 to human clinical trials.

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 added.

CXA-10 promotes defense and repair responses by utilizing the body’s own endogenous signaling pathways. The defense and repair responses can be applied to a number of underserved, life-threatening inflammatory-based diseases.

The company found acute kidney injury as the lead proof-of-technology indication due to the significant unmet need in this patient population.

Complexa also continues its work on oral chronic treatments and is likely 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 programs in other inflammatory, neurodegenerative and metabolic-related therapeutic categories are also under active evaluation.