BERWYN, Pa.--(BUSINESS WIRE)--Complexa Inc. today 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.”
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. More information about the trial is available at www.FIRSTx-trial.com or www.clinicaltrials.gov identifier NCT03422510.
About Focal Segmental Glomerulosclerosis (FSGS)
FSGS is a disease that attacks the kidney’s filtering units (glomeruli) causing serious “protein spilling” and tissue scarring which leads to permanent kidney damage and even kidney failure requiring dialysis. More than 100,000 individuals in the United States are living with FSGS, with approximately 7,000 new cases diagnosed yearly. FSGS occurs more frequently in adults than in children and is most prevalent in adults 45 years or older. FSGS is most common in people of African American and Asian descent. The most common symptoms are protein in the urine (proteinuria) and swelling of the extremities (edema).
FSGS is classified as primary or secondary based on the etiology of the disease. Primary FSGS occurs for unknown reasons and is commonly associated with nephrotic syndrome, whereas secondary FSGS results from other medical conditions. FSGS is progressive, causing scarring (fibrosis) in the kidney that leads to kidney failure. A reduction in the amount of protein in the urine as a result of treatment indicates improved kidney function.
CXA-10 is an oral nitrated fatty acids (NFA) which impacts the fibrotic and inflammatory pathways. CXA‑10 acts through key reparative, metabolic and inflammatory pathways, including upregulation of the Nrf2 pathway and inhibition of Nuclear factor-kappa B. In addition, CXA-10 increases the expression of heat shock proteins, which act as chaperones during cellular stress. In six Phase 1 clinical trials, CXA-10 demonstrated target engagement, and was shown to be tolerable and safe in more than 100 subjects. Importantly, CXA-10 has demonstrated impact on relevant biomarkers of pharmacological action as well as inhibition of key biomarkers of disease-related inflammation and fibrosis.
Complexa Inc. is a patient-focused, science-driven, clinical stage biopharmaceutical company developing a novel class of compounds, nitrated fatty acids (NFAs), for the safe and effective treatment of debilitating fibrotic and inflammatory diseases. NFAs have demonstrated broad potential to be effective therapeutic agents in multiple disease indications in which oxidative stress, inflammation, fibrosis and/or direct tissue toxicity play significant roles. This class of molecules has the potential to be disease-modifying in many disorders, given NFAs’ broad activity. An experienced consortium of investors, including Andera Partners, HBM Healthcare Investments, JAFCO, New Enterprise Associates (NEA) and Pfizer Venture Investments have committed funding to advance a platform of NFA agents across multiple orphan disease indications. Complexa’s lead candidate, CXA-10, is currently in Phase 2 development for focal segmental glomerulosclerosis (FSGS) and pulmonary arterial hypertension (PAH). For more information, visit www.complexarx.com.
About Kidney Research Network
The Kidney Research Network is a collaborative organization of patients, clinicians, and scientists focused on improving evidence-based treatment options and outcomes for patients with kidney disease. Supported by a Patient Advisory Board, the Network consists of six cores and employs strategic partnerships to advance its mission. The Clinical Trials Network and Trials Consulting Core along with full-service Data Analysis and Coordinating Center provides a unique, high impact approach to clinical trial development and execution and leverages the rich resources of the Network Data Warehouse and Endpoints and Outcomes Consortium. To learn more, visit www.kidneyresearchnetwork.org.