Travere Therapeutics Inc TVTX announced topline primary efficacy results from the Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS).
FSGS is a rare kidney disease defined by progressive scarring of the kidney resulting in proteinuria and rapid decline in kidney function.
The study did not achieve its primary efficacy endpoint, with only a 0.3 mL/min/1.73m2 difference in eGFR total slope compared to active control irbesartan after 108 weeks and a 0.9 mL/min/1.73m2 difference on eGFR chronic slope.
After 108 weeks of treatment, patients treated with sparsentan achieved a mean reduction in proteinuria from baseline of 50.0% compared to 32% for irbesartan.
FSGS partial remission of proteinuria endpoint was achieved by 38% versus 23% of patients, and complete remission was achieved by 18% and 7% of patients, respectively.
A preliminary review of the safety results through 108 weeks of treatment indicates sparsentan has been generally well-tolerated and has a favorable safety profile.
William Blair writes that while the failure brings the likelihood of approval in FSGS into question, the totality of the data suggests that sparsentan has a therapeutic benefit in FSGS.
The analyst says there is still a chance of approval and is lowering the probability of success in the indication from 85% to 40%.
Price Action: TVTX shares are down 24.8% at $17.38 premarket on the last check Tuesday.
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