The First Patient Has Been Dosed in a Clinical Trial of a Drug to Treat FSGS

The biopharmaceutical company Complexa, Inc., has announced that the first patient has been dosed on the Phase 2 clinical trial FIRSTx. FIRSTx is a study of the experimental drug CXA-10 for the treatment of primary focal segmental glomerulosclerosis (FSGS). You can read the full article here, at BioPortfolio.
FSGS is a condition that affects the kidneys. People with FSGS have damage to their glomeruli, which are involved in filtering the urine. As a result, substances that would usually be separated out, such as proteins, are able to pass into the urine, and the kidneys are progressively damaged. The condition can either be primary, which has an unknown cause and is often associated with nephrotic syndrome, or secondary, which refers to FSGS linked to other medical conditions. Many people experience swelling and high protein levels in the urine as a result of FSGS, but others don’t have any symptoms. FSGS most often occurs in adults, especially those over 45 years of age. Approximately 40,000 people in the United States are thought to have FSGS.

The experimental drug, CXA-10, is a possible treatment for FSGS. It is taken orally and functions by affecting the inflammatory and fibrotic pathways. Francisco Salva, the CEO and President of Complexa, says that there is not currently an FDA approved treatment for FSGS, and the condition is usually managed through steroids. He says that CXA-10 might help patients “avoid the debilitating side effects of steroids, improving their quality of life.” Five Phase 1 trials found that CXA-10 showed target engagement when given in the doses being used in the Phase 2 trials. It was also tolerable and safe in the 100 subjects tested.

As the next stage of clinical testing, CXA-10 will now be evaluated for safety and efficacy in FSGS patients in a Phase 2 clinical trial called FIRSTx. The first patient enrolled in FIRSTx has just been dosed. It is a randomised, open-label (patients know what drug they are receiving) trial that will take place in around twenty centres in the US. Patients involved will be 18 or older, newly diagnosed with primary FSGS, and treatment-naïve. The researchers anticipate enrolling around 30 patients. The study involves two groups, each of which will receive a different dosage of the drug for three months.
Researchers will be primarily be looking for reduced proteinuria (protein in the urine), but will also track other markers, including signs of nephrotic syndrome, kidney function, and patient reports.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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