Biopharmaceutical company Travere Therapeutics Inc. (TVTX:NASDAQ), which concentrates it efforts on creating and delivering therapies for treating rare diseases, today announced "positive topline interim results from the ongoing pivotal Phase 3 PROTECT study of sparsentan, an investigational product candidate for the treatment of IgA nephropathy (IgAN)."
Travere Therapeutics advised that the PROTECT clinical trial successfully achieved its interim efficacy endpoint with statistical significance and that those treated with sparsentan showed a higher than threefold reduction of proteinuria from baseline following 36 weeks of treatment versus the control group which was administered irbesartan.
The firm indicated that sparsentan was well-tolerated in the study and added that based upon the positive data observed in the PROTECT study, it intends to submit an application for accelerated approval in the U.S. during H1/22 along with an application for conditional marketing authorization in Europe.
Travere Therapeutics' CEO Eric Dube, Ph.D. commented, "IgAN is a leading cause of end-stage kidney disease, and there is a clear need for novel treatment options to slow the progression of this devastating rare kidney disorder...These data from the PROTECT study further demonstrate sparsentan's ability to significantly reduce proteinuria and support its potential to become a new foundational treatment for people living with IgAN, if approved."
"We look forward to engaging with regulators as we prepare for accelerated approval submissions beginning in the first half of next year," Dube added.
The company listed that to date 404 adult patients with persistent proteinuria despite active ACE or ARB treatment have been enrolled in its ongoing multicenter Phase 3 PROTECT study. Participants in the trial were given a once daily dose of either 400mg sparsentan or 300mg irbesartan, the active control.
The study was designed to allow for an unblinded interim analysis to be performed in order to evaluate the primary efficacy endpoint, which was identified as "the change in proteinuria (urine protein-to-creatinine ratio) from baseline at week 36." The topline data from the first 280 randomized patients who completed 36 weeks of treatment showed that patients who received sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to just 15.1% for irbesartan-treated patients.
The company's Chief Medical Officer Noah Rosenberg, M.D. remarked, "Sparsentan has now demonstrated in one of the largest interventional studies to date in IgAN, a statistically robust and clinically meaningful proteinuria reduction relative to a current standard of care…These data build upon our Phase 2 DUET and Phase 3 DUPLEX studies in FSGS and further strengthen the support for our novel approach with sparsentan as a dual endothelin-angiotensin receptor antagonist being developed for rare kidney disorders."
The firm stated that the PROTECT study's secondary endpoints include "the rate of change in estimated glomerular filtration rate (eGFR) following the initiation of randomized treatment over 58-week and 110-week periods, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment." The company noted that that preliminary eGFR data gathered was very positive and suggests that sparsentan may offer a clinically meaningful treatment effect after two years.
Travere advised that it expects to provide a regulatory update in Q3/21 on its pivotal Phase 3 DUPLEX study of sparsentan for focal segmental glomerulosclerosis (FSGS) treatment.
The company described sparsentan as "a dual endothelin angiotensin receptor antagonist (DEARA)." The firm stated the "preclinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation."
Travere Therapeutics is a biopharmaceutical company based in San Diego, Calif. that is focused on developing and delivering therapies to people with rare diseases. The company's drug investigational development pipeline includes sparsentan for use in treating IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS).
According to the company, sparsentan has received orphan drug designation in both the U.S. and Europe for use in treating IgAN and FSGS.
Travere Therapeutics began the day with a market cap of around $938.1 million with approximately 60.7 million shares outstanding and a short interest of about 11.2%. TVTX shares opened 33% higher today at $20.57 (+$5.12, +33.14%) over Friday's $15.45 closing price. The stock has traded today between $17.05 and $21.34 per share and is currently trading at $18.03 (+$2.58, +16.7%).
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