First Patient Dosed in the Complexa Phase 2 Trial of Lead Candidate CXA-10 to Treat a Rare and Severe Form of Kidney Disease, Focal Segmental Glomerulosclerosis
BERWYN, PA, June 1, 2018 – Complexa Inc. today 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.
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. An estimated 40,000 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. In some cases, there are no symptoms of the disease; however, 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 origin 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 NFA compound 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 and Toll-Like Receptor 4 pathways. In addition, CXA-10 increases the expression of heat shock proteins, which act as chaperones during cellular stress, and inhibits xanthine oxidoreductase to reduce oxidative stress. In five Phase 1 clinical trials, CXA-10 demonstrated target engagement at the specific doses being used in Phase 2, 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.
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