Gilead-partnered Glympse snares $46.7M for their NASH-snooping biosensors
Since its emergence at JP Morgan six years ago, the NASH field has been held back not only by the question of how to treat the disease, but also by the question of how you diagnose it. It’s simply not that difficult to tell if a liver is fatty or scarred or in full-on cirrhosis.
The method used in most trials is needle biopsy, where you take a hollow needle, stick it through someone’s skin and into their liver and suck out some cells. You stain those cells and examine them under the microscope. It’s safe but very painful, and that pain limits how often you can test a patient in a trial, and, down the line, how many of the millions of Americans suspected to have NASH would actually be tested for the disease and potentially prescribed an approved drug.
Which is why Glympse Bio was able to raise a $22 million Series A two years ago off their NASH diagnosis platform and land a collaboration with Gilead, arguably the largest company making a major push into the field. And why today, they were able to land another $46.7 million in a Series B from Section 32 and more than 10 other investors to bring that platform closer to use in trials and doctors’ offices.
“In NASH specifically there’s a real need for a technology that can both diagnose disease and predict treatment response,” Glympse CEO Carolyn Loew told Endpoints News. “What we have the ability to do is detect real-time biological changes at the site of disease.”
Glympse is one of several different companies trying to develop better diagnostic tools for NASH. Genfit is developing a blood-based test, one that appears likely to become an increased focus for the company after the NASH drug went bust in Phase III earlier this year. Intercept has used a range of experimental metrics alongside traditional ones in their most recent trials.
Glympse’s platform involves injecting into patients tiny biosensors that are meant to “query” the body for disease. Basically, they measure the proteases, powerful cutting enzymes that are disregulated in inflammatory conditions and cancers. Investigators collect those sensors from urine to get a measurement. “It’s safe, repeatable, non-invasive,” Loew said.
The idea is that these sensors can detect patients who have NASH or are at risk of developing NASH better than needle biopsies that are used to detect liver scarring or the scans that are used to detect fatty buildup, both of which can be inaccurate. The accuracy of the needle biopsy, in particular, can depend on where in the liver you prick.
“The sample you take is very variable and how pathologists read the slides is also very variable,” Loew said. “So you’ve got this inherent variability.”
The sensors are also supposed to be able to predict and detect response to treatment. In the long term, Loew said, they could be used to test patients for NASH or NASH risk earlier than currently possible and figure out quickly whether or not a therapy works. In the shorter term, Glympse is working with Gilead to select patients for their clinical trials and quickly measure if the drug is working, allowing the California drugmaker to decide faster if further investment is worthwhile.
Meanwhile, Glympse is also developing biosensors for cancer and infectious disease. The infectious disease program remains under wraps — a Covid-19 test, maybe? — but the idea behind the cancer program is that it will allow clinicians and drug developers to know much quicker than currently possible whether a drug is having a biological effect, allowing a doctor to switch therapies or a company to focus resources elsewhere. Loew said it will be particularly important for immunotherapies, which often take longer to show their effects.