Emerging Drug Developer: Reata Pharmaceuticals

Reata lassoes some hard-won attention

For a biotech with solid venture backing, some 50 employees and a significant licensing deal under its belt after reeling in convincing mid-stage data on a promising program for chronic kidney disease, Reata Pharmaceuticals made it through the last year with precious little media coverage.

And it's not hard to see why. While colleagues beaver away in the limelight of Boston, South San Francisco or San Diego, Reata is in Irving, Texas, not far from the sprawling DFW International Airport. That leaves the developer close to one of the world's biggest traffic hubs, and a long stretch from the biotech hubs which garner the bulk of the industry's coverage.

But Reata CEO Warren Huff is hoping that this coming year could make it impossible to ignore the company any longer. And bardoxolone, dubbed RTA-402, is his ticket to the center stage.

Originally, Reata--which launched in 2002, inspired by the scientific work undertaken by Mike Sporn at Dartmouth Medical School--had set out to study the therapy's effect on cancer. But a funny thing happened on the way to a Phase III oncology study. In one cancer study researchers saw a big improvement in renal function among all renal cancer subjects. Arrested progression of chronic kidney disease or recovered kidney function was a provocative finding, says Huff. So Reata mounted two Phase IIa trials for CKD in 2008. Those studies wrapped last year.

The body's key signpost here is the GFR, the rate of filtration in the kidneys. When you're young, explains Huff, your GFR usually runs at a robust pace of about 120. With CKD, the rate plunges to half of that. And when dialysis commences, it typically sinks down to the low double digits.

"It's just a steady march down," says Huff, with hypertension and other conditions cutting it at every step. Bardoxolone, which activates the Nrf2 gene, a trigger in the production of more than 250 antioxidant and detoxification proteins, appears to reverse that trend.

In their Phase IIa trials, a large majority of patients saw their GFR rate improve. Says Huff: "That's never been reported before."

That kind of data has set the stage for the company's new set of priorities. Huff wants to see if a Phase IIb trial with more than 200 patients can gin convincing six- and 12-month data.

"The regulatory agencies recently gave us feedback that they would take IIb as pivotal, particularly if GFR was improved from baseline," says the CEO. From there the company could run a confirmatory Phase III. That would put Reata on track to a potential approval in the second half of 2011 with a 2012 launch date.

Reata has enough money in the bank and in promised reserves to get to an NDA.

"At the end of 2008, in all the chaos, we raised an F round of $32 million," says Huff. "That was led by Novo A/S, and a large hedge fund, CPMG. And then we raised a Series G in two tranches. We closed the first $17 million tranche in September of ‘09 and a $63 million second tranche is conditioned off of the primary endpoint data."

Just last week Reata scored a $272 million licensing pact with Kyowa Hakko Kirin covering Japan and a slate of key Pacific Rim countries, with $35 million of that arriving as an upfront payment.

 "The renal field is one of three strategic focuses of the company," says Ken Yamazumi, Ph.D., COO of Kyowa Hakko Kirin. "CKD is a large and rapidly growing problem in Japan and the rest of Asia, and the Phase II data with bardoxolone suggests for the first time that a drug may be able to arrest or reverse progression of the disease."  

"Our strategy is to go all the way," says Huff, "keep a substantial interest and make the transition to a commercial enterprise. That drove the interest in an Asia-only deal." From here, the company could strike another offshore pact or possibly arrange a co-promotion deal in the U.S.

"I would think somewhere along the way we would want to be public," says the CEO. "It depends on what we do with the rest of the world rights. We'd have to raise capital to make the transition." Then there are inflammatory conditions to explore, along with the original range of cancer studies to pursue.

"I think we have the biggest commercial opportunity out there," says Huff.

Emerging Drug Developer: Reata Pharmaceuticals
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