Travere Therapeutics made waves on Thursday with a dramatic Phase III showdown for its kidney disease wonder drug, sparsentan, affectionately known as Filspari. The stage was set for a high-stakes battle to confirm its efficacy in a fierce duel against the relentless IgA nephropathy (IgAN), where protein buildup in the kidney’s glomerulus had waged a prolonged war.
In the red corner, sparsentan, the up-and-coming contender, went toe-to-toe with the seasoned champion, irbesartan, a tried-and-true treatment for IgAN. A thrilling 404-patient match ensued, with proteinuria, or excessive protein in the urine, as the heavyweight title.
In the early rounds, sparsentan showcased impeccable safety, earning cheers from the crowd with a consistent safety record. But as the battle progressed, the efficacy results left fans on the edge of their seats.
Sparsentan fought valiantly, preserving kidney function for the long haul and delivering a substantial boost to the estimated glomerular filtration rate (eGFR). However, in a heart-stopping twist, it narrowly missed landing a knockout punch on the eGFR total slope, a pivotal endpoint.
Despite this nail-biting showdown, sparsentan clinched a victory in the eGFR chronic slope, raising hopes for regulatory approval in the EU. Currently, the drug enjoys accelerated approval from the FDA, granted earlier in 2023, on the promise of its urine protein-reducing prowess.
But the real drama unfolded in the stock market, where investors witnessed a breathtaking 40% nosedive in Travere’s share price during pre-market trading on Thursday.
And that’s not all the turbulence Travere faced in the ring. In another corner of the arena, a separate Phase III battle tested sparsentan’s mettle against focal segmental glomerulosclerosis (FSGS), a rare kidney disease. However, the outcome was far from triumphant, as the drug failed to make a significant impact on kidney function.
Travere’s CEO, Eric Dube, described the FSGS results as “disappointing” but hinted at exploring possible avenues with regulators to keep sparsentan in the fight.
In the world of kidney disease treatment, Travere’s rollercoaster journey continues to captivate, leaving both hope and uncertainty in its wake.