As part of its efforts to change its focus from technology to drug development, Xsira Pharmaceuticals Inc. added its first clinical-stage product to its GPCR-based pipeline.
The company, formerly known as Norak Biosciences, licensed worldwide rights to develop adenosine in surgical indications from Harbor-UCLA Medical Center. Financial terms of the deal were not disclosed, but Xsira gains rights to eight patents and intends to submit previously published clinical data when it files an investigational new drug application in the next few months.
The adenosine compound "had been in the clinic under physician-sponsored INDs and had been studied in an excess of 300 patients," said Terry Willard, executive vice president of Xsira. "We hope to be back in the clinic under an Xsira-sponsored Phase IIb study by the fall."
Published data suggest that an intra-operative infusion of adenosine might reduce patients' pain scores immediately following surgery, as well as reduce the need for opioids and the side effects stemming from opioid use. Those studies also show the potential for faster recovery and earlier hospital discharge.
As a surgical analgesia, adenosine would have "a very large and diverse market," Willard said. "Xsira also has acquired patents to other applications," which have not yet reached the clinical stage.
"We are pursuing other synergistic opportunities in the surgical area," he told BioWorld Today. "Our goal is to make the company into a commercial entity when the time is right, and we would like to have more than one product in the same setting to help justify that investment."
The adenosine-based compound seemed a natural addition to Xsira, particularly given the experience of President and CEO Roger Blevins, who previously helped develop and commercialize two adenosine products - Adenocard and Adenoscan - while heading Medco Research Inc., a company acquired in 2000 by Bristol, Tenn.-based King Pharmaceuticals. Blevins co-authored the new drug applications, and those products continue to be marketed in the U.S. and Europe.
Adenosine also complements the other areas of Xsira's discovery efforts since it is based on a G protein-coupled receptor, the basis for its early stage pipeline. The company was founded on drug discovery technology called Transfluor that was spun out of Duke University, and then "scaled up and commercialized and licensed to major pharma companies" for their discovery programs. Meanwhile, Xsira would take those licensing fees and "plow them back into our own drug discovery program," Willard said.
But the company decided last year to leave the licensing business behind and focus on drug development, he said.
Xsira sold its Transfluor technology in March to Sunnyvale, Calif.-based Molecular Devices Corp. for $11 million, which Willard said provided Xsira capital to reinvest in drug development without another financing round. Before the Transfluor sale, the private company had raised about $23 million in venture capital.
The Research Triangle Park, N.C.-based company's research and early discovery efforts yielded some interesting compounds, which now are in proof-of-concept animal studies, Willard said, with potential indications in asthma, congestive heart failure, inflammatory disease and osteoporosis.
With multiple programs and early stage compounds, Xsira's plan is to seek partners for those products, either through licensing or collaborations, to push them into the clinic. That would allow the company to focus almost solely on developing later-stage compounds, such as the recently licensed adenosine.
"We think that's the best positioning for the current capital market environment that we're facing and likely to face in the next few years," he said.
In January, the company changed its name from Norak to Xsira, a decision spurred by its shift to a product-based firm and to "get away from the toolbox identity," Willard said.