Reata Pharmaceuticals (NASDAQ:RETA) announces positive results from the Phase 3 part of its Phase 2/3 clinical trial, CARDINAL, evaluating bardoxolone methyl in patients with chronic kidney disease (CKD) caused by a rare inherited disorder called Alport syndrome.
The study met the primary endpoint of statistically valid increase from baseline to week 48 in a measure of kidney function called eGFR (estimated glomerular filtration rate) compared to placebo. Key secondary endpoints were also met.
No safety signals were observed versus the Phase 2 portion.
According to the company, the FDA indicated that a demonstrated improvement in eGFR after one year of treatment may be sufficient to support accelerated approval.
The company will host a conference call tomorrow, November 12, at 8:00 am ET to discuss the data and Q3 results.
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