Reata Scores $78M to Test CKD Candidate in Second Phase III Trial

Data from first study with bardoxolone methyl will be released in November.

Reata Pharmaceuticals completed a $78 million equity financing led by existing investors CPMG and Novo. It will fund the second of two pivotal trials of Reata’s lead product candidate, bardoxolone methyl, in patients with advanced chronic kidney disease (CKD) and type 2 diabetes.

The primary endpoint of the ongoing first pivotal trial was recently analyzed and the data will be presented at a scientific meeting in November, Reata says. “We are looking forward to initiating the second pivotal trial of bardoxolone later this year and remain on track to make this important new therapy available to CKD patients in 2012,” remarks Warren Huff, Reata’s CEO.

Reata plans to build a commercial organization in the U.S. to launch bardoxolone. In December 2009, it inked a deal with Kyowa Hakko Kirin to jointly develop bardoxolone in Japan and certain other Asian markets. The company says that it plans to seek a partner for development and commercialization in Europe and other worldwide markets.

In two Phase II trials bardoxolone significantly improved kidney function in patients with advanced CKD and type 2 diabetes. Ninety percent of patients in these studies experienced an increase from baseline in estimated glomerular filtration rate (eGFR), according to Reata. More than 70% of patients classified as Stage 4 CKD at baseline improved to Stage 3 CKD, the firm adds.

Founded in 2002, Reata Pharmaceuticals is developing oral anti-inflammatory drugs targeting Nrf2, which controls the body’s production of antioxidants. Nrf2 has been shown to protect against a broad range of diseases associated with inflammation and oxidative stress, according to the company. Including the current financing, Reata has raised $180 million since its inception.

This most recent round of funding will also be used to advance other potential products from the firm’s preclinical pipeline into clinical development, notes Huff. Other antioxidant inflammation modulator programs include one in CNS diseases like multiple sclerosis and another in respiratory diseases like COPD.

The firm also has a SOD1-folding stabilizer, RTA 801, in preclinical development against amyotrophic lateral sclerosis. The molecule was identified on Reata’s protein folding drug discovery platform.