Travere ( TVTX Quick Quote TVTX - Free Report) announced positive interim top-line data from the ongoing pivotal phase III PROTECT Study evaluating sparsentan, an investigational drug for the treatment of IgA nephropathy (“IgAN”), a rare kidney disorder.
The study met its primary efficacy endpoint with statistical significance. It demonstrated a greater than threefold reduction of urine protein-to-creatinine ratio (“proteinuria”) from baseline after 36 weeks of treatment with sparsentan, which achieved a mean reduction of 49.8% compared to irbesartan that attained 15.1%.
The secondary efficacy endpoints from the PROTECT study include the rate of change in estimated glomerular filtration rate (“eGFR”), following the initiation of randomized treatment over 58-week and 110-week periods and the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment. Travere believes that the preliminary eGFR data available at the time of the interim analysis are indicative of a potential clinically meaningful treatment effect after two years of treatment.
Based on data from the interim analysis, Travere plans to submit applications for accelerated approval in the United States in first-half 2022 and conditional marketing authorization in Europe.
Shares of the company surged 15.3% on Aug 16, following the above-mentioned news. Yet, the stock has declined 34.6% so far this year in comparison with the
industry’s 1% decline. Image Source: Zacks Investment Research
Per the company, the PROTECT study will continue to fully assess the treatment effect on eGFR slope over 110 weeks in the confirmatory endpoint analysis. The company anticipates top-line data from the confirmatory endpoint analysis in second-half 2023.
Travere is also evaluating sparsentan to treat focal segmental glomerulosclerosis (“FSGS”) in a phase III DUPLEX study. In May 2021, the company conducted pre-NDA interactions with the NDA for the drug’s accelerated approval on the basis of positive interim data from the DUPLEX study. However, the FDA did not accept the interim data analysis and requested for additional data from the study. A type A meeting is expected to take place in the ongoing quarter.
We inform investors that sparsentan was granted Orphan Drug designation in the United States and Europe for the treatment of IgAN as well as FSGS.
Zacks Rank & Stocks to Consider
Travere currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include
Horizon Therapeutics ( HZNP Quick Quote HZNP - Free Report) , Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) and Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) . While Horizon and Repligen each carry a Zacks Rank #1 (Strong Buy) at present, Vertex currently holds a Zacks Rank #2. You can see . the complete list of today’s Zacks #1 Rank stocks here
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