NEW YORK(GenomeWeb) – Israeli biotech firm MeMed announced this week that it has won a €3 million ($3.3 million) grant from the European Commission's Horizon 2020 Small to Medium-Sized Enterprise program.
According to Founder and CEO Eran Eden, the company will use the funds to develop a point-of-care version of its proteomic test to distinguish between viral and bacterial infections and to support a clinical study investigating the test's usefulness in diagnosing elderly patients with lower respiratory tract infections (LRTIs).
Launched in 2009, MeMed grew out of a research project by Eden and his MeMed Co-founder and current Chief Technology Officer Kfir Oved. The company's lead product, which it has launched on an early-access basis in the EU, Switzerland, and Israel, is a protein biomarker test for determining whether an infection is viral or bacterial.
The test, named ImmunoXpert, is intended to guide physician antibiotic use with the goal of addressing the problems of overuse and the subsequent development of bacterial antibiotic resistance. Unlike bacterial infections, viral infections are not typically susceptible to antibiotics, but because it can be difficult to quickly tell the difference between the two, antibiotics are often prescribed to treat viral infections.
Earlier this year, the company published in PLOS One data from a 1,002-subject clinical study in which its three-protein signature distinguished between bacterial and viral infections with an area under the curve of .94.
Now, MeMed is looking to apply the test to more specific subpopulations, with a current area of focus being elderly patients with LRTIs, Eden told GenomeWeb.
"The technology we have developed can be used for many indications and subpopulations, and after you demonstrate it broadly you have to decide where you want to focus next," he said, noting that the company has taken aim at elderly LRTI patients due to the significant clinical and economic need.
Determining whether an LRTI is viral or bacterial can be particularly challenging in elderly patients, Eden said. "So there is a lot of overuse of antibiotics in this particular subpopulation, while at the same time there is also underuse – basically a lack of antibiotic prescription or delays in prescribing."
He added that in elderly populations, failure to prescribe or delays in prescribing antibiotics is more likely to lead to prolonged disease and complications or even death.
"So from a clinical perspective, it is really needed," he said. And, he noted, from a health economic perspective, quickly determining whether an LRTI is bacterial or viral could lead to significant savings by reducing antibiotic overuse or reducing patient complications.
Using funds from the Horizon 2020 award, MeMed will this year start a multi-center prospective study looking at around 1,000 elderly patients with LRTIs. Eden said he expected the study to take roughly two years to complete.
Beyond providing additional data on ImmunoXpert'sperformance, the study will collect data on how it influences physician decision making and what economic benefits it provides.
The study will also look at the performance of other biomarkers and diagnostics currently used in routine care of infectious disease, Eden said. "I think it's very important to build a very broad perspective to understand the advantages and disadvantages of your product."
The test has CE-IVD approval in the EU, Switzerland, and Israel with the intended use population including the elderly patients MeMed will be studying in the upcoming trial. As such, Eden said, the trial is aimed less at validation and more at supporting clinical utility in "the real world setting... getting key opinion leaders on board and starting to penetrate the market."
"We already have a significant amount of data around this indication in elderly patients, and it works robustly on this population," he said. "This [study] is just going to expand on that data with additional blinded, prospective validation. Data is king, so we want to create more and more data to support our initial studies."
MeMed is also using the Horizon 2020 funds to support development of a point-of-care version of the test. The current version of the test has a turnaround time of roughly two hours and is aimed primarily at the hospital market. The point-of-care version, which the company hopes to submit for regulatory approval in the EU in around two years, will deliver results in 15 to 20 minutes, which will make it suitable for settings like doctor's offices.
"Development of [that] platform is expensive,"Edensaid, noting that the award will not "cover all the costs" but that the company has the funds to develop and launch the platform on its own dime.
MeMed has been through three funding rounds, with participation from what Eden characterized as a number of "blue-chip" venture capitalists in Silicon Valley and Asia. He declined to say how much the company, which has 19 employees, has raised since its launch.
He noted that in addition to the award announced this week, the company has received funds through the EU's Tailored-Treatment consortium, a €6 million project to develop and validate diagnostics to improve management of hospitalized patients with infections that the company initiated.
Looking beyond the elderly LRTI patient population, MeMed has identified the pediatric space — and LRTIs and fevers without source in particular — as also among its main areas of interest, Eden said.
"Each is a world in its own and a huge market," he said, adding that the company is currently running several multi-center prospective studies in these areas.
While MeMed has thus far focused most of its efforts on Europe and Israel, the company is also looking to move into the US market.
"That is definitely part of our strategy," Eden said, though the company has not yet begun discussions with the US Food and Drug Administration regarding the test.