News Article

Leveraging the immune response to build next-gen precision diagnostics for infectious and inflammatory diseases
Date: Mar 09, 2020
Author: Ben Adams
Source: Fierce Biotech ( click here to go to the source)

Featured firm in this article: Inflammatix Inc of Burlingame, CA

The scoop: Inflammatix is working on a series of diagnostics to assess the most serious bacterial and viral infections as quickly as possible. The medtech recently tied up a contract with BARDA aimed at developing its tests for acute infections and sepsis as it looks to speed up diagnosis and get treatment to these patients ASAP, while also reducing the need for antibiotics and curbing antimicrobial resistance.

What makes Inflammatix fierce: There is, rightly, a lot of focus on testing for cancers, which are tough to treat and often fatal. Infection can prove much more deadly than even cancer, however, and can kill an otherwise healthy person in days or even hours. It's easy to forget how many millions of people around the world die each year as a result of sepsis and other acute viral and bacterial infections such as pneumonia.

Getting an accurate, speedy result when one of these more dangerous infections is present is paramount. Every hour counts, and the longer the delay, the higher the risk of serious side effects and death from the infection.

Current methods for diagnosing acute infections are often inaccurate or too slow. As a result, patients with suspected infection are often blindly treated with antibiotics, which also contributes to antibiotic resistance. Deadly infections, such as sepsis, can be missed altogether.

Inflammatix's co-founders, CEO Tim Sweeney, M.D., Ph.D., and COO Jonathan Romanowsky, say this is where they want to change things. The company is working on a platform that doesn't scan for pathogens but rather is focused on using the immune response of a patient--and using it quickly.

"The tools that are available today don't work well enough. That's because it's really hard to find pathogens. Building a pathogen-based test is focused on testing for bacteria in the bloodstream, but less than half of patients with sepsis have bacteria in the bloodstream, so a negative test here might not mean a patient doesn't need antibiotics."

If you go into the hospital now with suspected pneumonia or another acute respiratory infection, you get a battery of tests: nasal swabs, cultures, urine tests and others. But a study in the New England Journal of Medicine says that this battery of tests only shows the pathogen 38% of the time compared to when you perform a chest X-ray--the main, surefire way to see if a patient has pneumonia.

Sweeney says this means that ultimately doctors are guessing whether a patient has pneumonia or not, even after these tests. And there's a two-prong problem here: One is the slow and often inaccurate testing, and the other is a playing-it-safe approach, whereby anyone showing red flags for an acute respiratory infection is given antibiotics before knowing whether it is bacterial or viral.

"Physicians will not know what you have, but it turns out your immune system will know what you have," Sweeney says. "That's what Inflammatix is based on. The immune system reacts very differently when a pathogen comes into the body when it is either a virus or bacteria, or when there is no pathogen at all. So, we work by decoding signals in the blood so it can tell us what the immune system is reacting to."

This is done through messenger RNA, a molecule in cells that carries codes from the DNA in the nucleus to the sites of protein synthesis in the cytoplasm, known as the ribosomes. "With a small number of mRNAs, we can determine whether a patient has an infection; whether it's bacterial or viral; and can assess whether they may need ICU-level care," Sweeney says.

The test can work in under 30 minutes and has an easy-to-understand readout: If you're testing for a viral or bacterial-based infection, it will simply say which one it is. "The test itself is very complex," Sweeney says, "but the result is given to the physician as simply as possible."

It can also go further in helping battle antimicrobial resistance, a problem that's being made worse by the overprescription of antibiotics to patients who don't need them. If doctors know quickly and accurately that they're not dealing with bacterial pneumonia, they can have the confidence not to prescribe antibiotics, rather than prescribing them to play it safe.

HostDx Sepsis is the company's most advanced diagnostic, currently in registrational trials across U.S. hospitals to seek out sepsis; the company is hoping to file with the FDA in the middle of next year, with hopes for a 2022 approval.

It also recently published a paper in the journal Nature Communications, showing its molecular classifier delivered higher accuracy than standard biomarkers associated with acute infections and sepsis.

Inflammatix wouldn't release its pricing plan but said it would be within the range of other diagnostics in this area. Some training will be needed for healthcare workers using the test, but the company sees its diagnostic as bringing value for the price if it can help reduce those billions currently spent and potentially help save more lives and reduce antibiotic prescribing when it isn't necessary.

The company raised a $32 million series C round at the start of the year, and it also penned a BARDA cost-sharing contract that includes up to $72 million to develop its tests for acute infections and sepsis.