Pharma, Startups

Rival’s setback provides unexpected advantage for drug developer’s kidney injury therapeutic

Frequently, the path to commercial approval for a biopharmaceutical startup’s drug is filled with adversity. But […]

Frequently, the path to commercial approval for a biopharmaceutical startup’s drug is filled with adversity. But the drug development industry is also filled with unexpected twists. Last month, Pittsburgh-based Complexa unexpectedly lost a competitor for its chronic kidney disease therapeutic after Reata and Abbott Laboratories’ drug was pulled over safety concerns raised from an independent safety committee.

The move leaves just two companies developing what Complexa views as rival drugs to its own lead compound, which uses nitro fatty acid technology to reverse the effects of acute kidney injury induced by contrast agents used for cardiac angiography. The condition currently has no effective treatment, according to the company. AlloCure’s drug is in phase 2 development and Quark Pharmaceuticals is collaborating with Novartis for a drug in phase 1 development.

Other target markets for the compound include chronic kidney disease and contrast induced nephropathy.

Complexa CEO Joshua Tarnoff presented its kidney disease and kidney injury therapeutic at the Greater Philadelphia Alliance for Capital and Technology’s IMPACT conference this week.

The company is finishing off pre-clinical studies in the run-up to filing an IND for its lead compound in the second quarter of 2013. It is raising $10 million in a Series B round with the goal of funding two Phase 1 trials and one Phase 2 proof-of-concept study. Once that’s done, it wants to partner up with a pharmaceutical company and is currently in talks with some of them.

Among the past investors for the company are Pittsburgh Life Science Greenhouse, Scientific Health Development, Wistar Morris Foundation and UpStart.

Studies suggest that the incidence of contrast-induced acute kidney injury has fallen in the past 10 years, with current estimates that the condition affects about 7 percent to 15 percent of patients. Why? More people are aware of the problem, so there are better risk prevention measures in place and better contrast media with less renal toxicity. But with more and more procedures requiring contrast, it’s not a problem that’s going away.

[Photo Credit: Free digital photos user jscreationz]

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