Complexa, through its highly selective nitrated fatty acid platform, is developing medicines that down-regulate key inflammatory and fibrosis pathways while up-regulating key metabolic and repair pathways. Our compound library focuses on enhancing tissue protection and repair and inhibition of inflammation.
CXA-10 is an oral nitrated fatty acid compound that acts through a constellation of actions including:
Upregulation of Nrf2 pathways, a key pro-reparative and metabolic pathway
Inhibition of NF-Kappa B and TLR4, key drivers of inflammatory molecules and pathways
Inhibition of Xanthine Oxidoreductase, a key intracellular producer of Reactive Oxygen Species add that result in cellular oxidative stress
Increasing the expression of heat shock proteins, which act as chaperones during cellular stress to restore cellular homeostatic mechanisms
Extensive Foundational Data
In five Phase 1 clinical trials, CXA-10 has demonstrated proof of target engagement at the targeted doses for Phase 2 with differentiated safety in more than 100 subjects. Importantly, CXA-10 has demonstrated activation of target gene expression, not only in plasma, but within the kidney, and impact on relevant biomarkers of CXA-10 pharmacological action, with subsequent inhibition of key biomarkers of disease-related inflammation and fibrosis.
FIRSTx Clinical Trial in FSGS
The company is recruiting patients in FIRSTx, a Phase 2 open-label clinical study evaluating the safety and efficacy of CXA-10 to treat primary focal segmental glomerulosclerosis (FSGS). The study is being conducted at 20 sites within the US. Adult subjects may be eligible to participate if they have not been treated for FSGS with high dose, long term steroids (or other immunosuppressive therapy). The primary efficacy endpoint is reduction in proteinuria. Other efficacy endpoints include markers of nephrotic syndrome, kidney function (eGFR), and patient-reported outcomes. The FIRSTx clinical study is being conducted in partnership with Kidney Research Network (previously NephCure Accelerating Cures Institute) and the University of Michigan Coordinating Center. For more information about FIRSTx, visit http://firstx-trial.com/.
PRIMEx Clinical Trial in PAH
The company is recruiting patients in PRIMEx, a Phase 2 double-blind, placebo-controlled clinical study evaluating the safety and efficacy of CXA-10 to treat pulmonary arterial hypertension (PAH) while on background therapy. The primary endpoint of the study, which is being conducted at approximately 40 sites within the U.S. and five sites within the U.K., is the change from baseline in both Right Ventricular Ejection Fraction (RVEF) assessed by cardiac MRI and Pulmonary Vascular Resistance (PVR). For more information about PRIMEx, visit clinicaltrials.gov (NCT 03449524).
For more information about FIRSTx, visit: firstx-trial.com