Ligand Pharmaceuticals Incorporated’s LGND partner Retrophin, Inc. RTRX announced additional positive data results from the phase II DUET study on sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). The data was presented at the American Society of Nephrology Kidney Week.
The international, randomized, double-blind study evaluated the safety and efficacy of sparsentan in FSGS patients.
New data demonstrated that a significantly higher proportion of patients receiving sparsentan achieved modified partial remission of proteinuria, compared to those on the Avapro (irbesartan) arm. Moreover, a post-hoc, intention-to-treat analysis showed that the sparsentan treatment group again demonstrated a higher than two-fold reduction in proteinuria, in comparison to Avapro. In addition, four patients receiving sparsentan achieved complete remission, compared to zero irbesartan-treated patients. Moreover, sparsentan was found to be safe and well-tolerated.
We note that in Sep 2016, top-line data from the DUET study had demonstrated that the sparsentan treatment group achieved statistical significance in the study’s primary efficacy endpoint of reducing proteinuria.
The latest study results are encouraging. Retrophin is currently working with the FDA to determine the fastest path ahead for the development of sparsentan for an approval.
Per Ligand’s press release, FSGS is a rare kidney disorder without an FDA-approved pharmacologic treatment option. It is estimated that the disease affects up to 40,000 patients in the U.S. and has a similar prevalence in Europe. We note that sparsentan enjoys Orphan Drug status in both the U.S. and the EU for the treatment of FSGS.
Ligand carries a Zacks Rank #3 (Hold).
LIGAND PHARMA-B Price
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