Following a recent scientific workshop, there is growing excitement within the medical community about the potential of using proteinuria as a primary endpoint in clinical trials. Should this be embraced by regulatory bodies, it would have decidedly favorable consequences for treatments targeting conditions such as focal segmental glomerulosclerosis (FSGS). In light of these developments, expectations are being cautiously adjusted to include a projected market introduction for such therapies, with conservative estimates anticipating a launch year and the likelihood of successful outcomes.

Following the recent PARASOL Working Group meeting in Bethesda, MD, which brought together representatives from various sectors to deliberate on endpoints for focal segmental glomerulosclerosis trials, two primary insights emerged. Firstly, there is an incentive to transition away from eGFR as a trial endpoint in FSGS. Secondly, proteinuria is being considered as a potential validated surrogate endpoint within these trials. It is anticipated that Travere will seek a meeting with the FDA and aim to submit an sNDA in the first half of 2025. The final results from PARASOL are expected to be shared at the ASN meeting and in a scholarly publication. Additionally, should approval be granted, it could enhance Travere's attractiveness as a potential M&A target.

The completion of the PARASOL workshop has increased confidence in the potential approval of Filspari for the treatment of focal segmental glomerulosclerosis (FSGS), resulting in an enhanced probability of success estimate for Filspari in treating FSGS to 75% from the previous 60%.