The start of Q2 means the nearing of a big milestone for Pittsburgh drug startup Complexa Inc. — if it can raise the necessary capital.
Complexa is looking for a $7 million Series B so that it can file its Investigational New Drug Application early this summer and begin its first in-human trials in August.
The company is developing a synthetic form of nitro fatty acids, which occur naturally in the body to shut down harmful inflammatory pathways and activate the body’s protective mechanisms against inflammation.
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Its drug will first be applied to treat acute kidney injury that occurs from inflammatory reaction to dye injections used with certain types of medical imaging, such as coronary angiography. Called contrast-induced nephropathy, this complication is more likely to occur in certain patients, like the elderly and those with diabetes, and is a common cause of hospital-acquired acute renal failures.
A $3.4 million Series A last summer funded IND-enabling studies of CXA-10, which are nearly complete, said President and CEO Josh Tarnoff. The next round would support Phase 1A and 1B proof-of-concept studies of the company’s oral drug candidate. Because it leverages naturally occurring compounds, Complexa says there’s a low risk of toxicity.
A few other pharmaceutical companies are also targeting acute kidney injury — AlloCure and Novartis are a bit ahead with their Phase 2 drugs. Although it’s initially going after treatment of acute kidney injury, for which the regulatory pathway is relatively clear and quick, the company also sees future applications in a host of inflammatory conditions including chronic kidney disease, which would be the next target, Tarnoff said.
Complexa was founded in 2008 and is based in Pittsburgh.
