Reata Pharmaceuticals’ (NASDAQ:RETA) Phase II pursuit of bardoxolone in focal segmental glomerulosclerosis (FSGS) may be thwarted given proteinuria increases seen in other kidney disorder trials, said nephrologists.
A reduction in proteinuria is an important surrogate measure for treating primary FSGS and while experts said primary FSGS’ pathophysiology is not well understood, they noted proteinuria associated with bardoxolone treatment in other rare kidney disorders like IgA nephropathy as being detrimental to treating FSGS. This contradictory observation coupled with a checkered history of the drug’s failure to get approved in other indications made some experts wary about its FSGS prospects.
The Phase II PHOENIX study (NCT03366337) is enrolling patients with rare kidney disorders like primary FSGS, IgA nephropathy, chronic kidney diseases (CKD) associated with type 1 diabetes (T1D-CKD) and autosomal dominant polycystic kidney disease, split into separate cohorts. Twelve-week data from the FSGS cohort is expected in 1H19, according to a January company presentation.
The company announced positive data from the T1D-CKD and IgA nephropathy cohorts in September 2018, resulting in a 7.6% positive stock movement and analysts deem the FSGS data as material to Reata. Reata’s market cap is USD 2.2bn. Global revenues for bardoxolone across all indications in 2024 are estimated to be USD 1.2bn, as per GlobalData.