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NIAAA Provides $2.5M in SBIR and STTR Funding for Research Into Biomarkers of Alcohol Use

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By Adam Bonislawski

The National Institute on Alcohol Abuse and Alcoholism announced this week $2.5 million in funding for research into biomarkers to detect alcohol use and abuse and related organ damage.

The funding consists of $2 million in Small Business Innovation Research grants and $500,000 in Small Business Technology Transfer grants and will support high-throughput screening efforts to discover biomarker signatures useful for diagnostic and monitoring purposes, Kathy Jung, program director in the division of metabolism and health effects at the NIAAA, told ProteoMonitor.

With alcohol abuse in the US costing an estimated $170 million per year and alcohol-related events figuring in between 20 and 40 percent of hospital admissions and roughly 80,000 US deaths annually, alcohol-related biomarkers have a variety of potential uses, Jung said. These include forensic applications, monitoring usage in parolees and other restricted populations, and the early detection of alcohol-related organ damage.

While there are several alcohol-related biomarkers currently in use, including protein markers like serum glutamic oxaloacetic transaminase and carbohydrate-deficient transferrin, "there isn't any single test that's accurate enough and reproducible enough," Jung said, observing that current tests are only 60 to 70 percent specific.

The program RFA calls for the development of "biomarkers of cumulative alcohol consumption; biomarkers that distinguish between binge drinking, moderate drinking, and chronic drinking; biomarkers that distinguish relapse from previous alcohol consumption; biomarkers of alcohol-induced tissue damage, including brain damage, alcoholic liver disease (ALD), pancreatitis, immune disorders, cancer, cardiomyopathy, fetal abnormalities, and other tissue damage; and biomarkers to serve as trait markers of alcohol use disorder phenotypes."

The hope, Jung noted, is that by developing panels of biomarkers, as opposed to the single-marker tests currently available, researchers will achieve improved sensitivity and specificity.

"The theory is that alcohol consumption will affect physiology in a fairly complicated way and change the expression of enough proteins in different parts of metabolism predictably," she said.

The grants are not explicitly for protein biomarker work, Jung noted, "but proteomics is obviously one of the more likely [approaches] to succeed."

This March, researchers at the Penn State College of Medicine published a study in Biological Psychiatry in which they identified a panel of 17 plasma proteins capable of distinguishing between heavy alcohol use, normal alcohol use, and no alcohol use in cynomolgus monkeys.

Such a panel has a number of potential applications, Kent Vrana, chair of the pharmacology department at the Penn State College of Medicine and an author on the paper, told ProteoMonitor.

"Let's say you were under some judicial order not to drink," he said. "You'd love to have a test that asked, 'Have you had anything to drink in the last couple of weeks?' Or, for instance, for the folks who drive planes or are in active duty military, it might be nice to know if someone has been abusively drinking for some time."

Such a test could also be useful in "routine clinical settings," William Freeman, director of the functional genomics core at the Penn State College of Medicine and another of the paper's authors, told ProteoMonitor.

"The results come back and suggest that you're drinking a whole lot. It would allow physicians to use it as a way to start the conversation – 'Do you want to talk about this, would you like to see a specialist, talk to a psychologist?'"

The next step for the panel – for which the researchers have filed a provisional patent – is validating it in humans, Vrana said. The team has roughly 2,500 human samples available for analysis, and is working with investigators in Finland, at Yale University, and at San Francisco's Ernest Gallo Clinic and Research Center on the study.

He said that he and Freeman will likely pursue a partnership with a small business that will allow them access to the NIAAA program through the STTR initiative, which pairs private firms with academic collaborators.

By issuing the funding as SBIR and STTR grants, which are aimed primarily at private industry, the NIAAA is trying to move alcohol biomarker work out of academia and into a more applied setting, he suggested.

"What [NIAAA] is trying to do is to use the SBIR and STTR mechanisms to try to bridge that gap where so many things disappear," he said. "[Taking] discoveries that are made in academia and translating them and turning them into a product that's used in a clinic."

"It's a valuable mechanism to provide resources to incentivize us to build new partnerships that we hadn't previously had," Freeman said.

The RFA is "open to insights and progress at any stage along the biomarker development pipeline," Jung said, but she noted that due to the relative newness of the field, "anything that's going to have to do with a proteomic profile is most likely going to be toward the discovery end of the pipeline."

Researchers, not the NIAAA, will be providing samples for the work, and there will be "a fair amount of latitude by the applicants to design the experiments as they'd like based on whatever samples they have available," Jung said, adding that, while the initiative currently consists of only the single RFA, participants whose work shows progress will be eligible to reapply for additional funding in future stages of the program.

"In the very later stages of the biomarker pipeline, ultimately it gets into clinical [validation], and we'll have to involve larger companies," she said. "That really remains to be worked out."

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