BERWYN, PA — Complexa Inc. recently announced dosing of the first patient in FIRSTx, a Phase 2 clinical trial evaluating the safety and efficacy of the company’s lead candidate, CXA-10, to treat primary focal segmental glomerulosclerosis (FSGS). FSGS is a rare and severe form of kidney disease that can lead to permanent kidney damage and even kidney failure. CXA-10 is the first drug of a novel pharmacological class of oral compounds called nitrated fatty acids (NFAs) being developed for the treatment of diseases associated with fibrosis and inflammation.
“There are currently no FDA-approved treatments for FSGS, which is typically treated with very high doses of steroids. CXA-10 is a potent anti-inflammatory and pro-reparative molecule which may allow patients to avoid the debilitating side effects of steroids, improving their quality of life,” said Francisco Salva, President and Chief Executive Officer of Complexa. “Advancing CXA-10 into Phase 2 is an important milestone and a critical step toward helping patients with this life-threatening disease. Dosing the first patient in the FIRSTx trial demonstrates our commitment to finding solutions for patients suffering from rare diseases that have limited or no treatment options.”
FIRSTx is a Phase 2, multicenter, randomized, open-label clinical trial evaluating the safety and efficacy of oral CXA-10 to treat newly diagnosed, treatment-naïve patients 18 years of age and older with primary FSGS. The study will enroll approximately 30 patients who will be randomized into one of two possible dose titration regimens of CXA-10 and will receive treatment for three months. FIRSTx is being conducted by an innovative partnership between Complexa, the Kidney Research Network, University of Michigan Coordinating Center, and NephCure Kidney International, an organization committed to supporting research for FSGS.
The primary efficacy endpoint of FIRSTx is the reduction of proteinuria – the presence of abnormal quantities of protein in the urine which may indicate damage to the kidneys. Additional efficacy endpoints include markers of nephrotic syndrome (a serious kidney disorder), kidney function (based on estimated glomerular filtration rates), and patient-reported outcomes.
The FIRSTx trial is anticipated to be conducted at 20 clinical trial centers across the United States. More information about the trial is available at www.FIRSTx-trial.com or www.clinicaltrials.gov, identifier NCT03422510.
Source: Complexa Inc., 1055 Westlakes Drive, Suite 200, Berwyn PA 19312
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