Complexa Completes Patient Enrollment in Phase 2 FIRSTx Trial Evaluating CXA-10 in Focal Segmental Glomerulosclerosis

Complexa
Complexa expects to report top line results in the second half of the year

BERWYN, PA — Complexa Inc. announced the completion of patient enrollment in the FIRSTx study, 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).

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. The results of the initial 90-day dosing treatment phase are expected in the second half of 2020 with an open-label extension continuing into 2021.

“The completion of enrollment in the FIRSTx trial is a significant milestone for Complexa and Kidney Research Network. The trial surpassed its target enrollment and included adolescents, underscoring the need for new treatment options for this rare and severe form of kidney disease for which there are no FDA-approved treatments,” said Theodore (Theo) Danoff, MD, PhD, Chief Medical Officer of Complexa. “We believe CXA-10 has the potential to be a promising treatment for patients with FSGS to address the underlying metabolic, inflammatory and fibrotic drivers of this disease. We thank the patients, the clinical trial sites and the University of Michigan, the Kidney Research Network and Coordinating Center for all their collaborative efforts especially during the COVID-19 pandemic.”

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FIRSTx is a Phase 2, multicenter, randomized, open-label clinical trial evaluating the safety and efficacy of oral CXA-10 to treat immunosuppression-naïve patients 13 years of age and older with biopsy-confirmed primary FSGS. Patients are randomized to receive one of two dose titration regimens of CXA-10 for three months with eligibility for inclusion in the 270-day open label extension study. FIRSTx is being conducted at 24 clinical sites in the U.S. through an innovative partnership between Complexa, the Kidney Research Network, University of Michigan Data Coordinating Center, and NephCure Kidney International.

The primary efficacy endpoint of FIRSTx is the reduction in 24-hour protein to creatinine ratio from baseline to Day 90. Additional endpoints include markers of nephrotic syndrome (a serious kidney disorder), kidney function (based on estimated glomerular filtration rates), and patient-reported outcomes.

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More information about the trial is available at www.FIRSTx-trial.com or www.clinicaltrials.gov identifier NCT03422510.

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