On Monday, Gilead and Glympse Bio announced they are teaming up to better understand a fatty liver disease known as NASH, or non-alcoholic steatohepatitis. Specifically, the collaboration will use Glympse's synthetic biomarkers to determine how severe a patient's NASH is at the start of a clinical trial, and how well the patient is responding to treatment.
The deal is interesting on two fronts for Gilead.
The first is that Glympse's technology could make enrolling future clinical trials more effective, which suggests Gilead sees NASH as a long-term investment. Analysts at Raymond James weren't so sure that was the case following the biotech's third quarter earnings presentation last week, in which executives were unusually quiet about their ambitions in the space.
The only NASH program that got any real air time was ATLAS, a study testing multiple combinations of Gilead's most advanced drug, selonsertib, and two of its other experimental drugs. Results are expected before the end of this year, and Gilead CEO Daniel O'Day said the data will shape his company's NASH strategy moving forward.
Gilead was a front-runner in NASH until early this year, when selonsertib failed in a couple late-stage studies. The setbacks potentially put Gilead years behind Intercept Pharmaceuticals in the race to get a NASH drug to market.
"Speaking with the company, we didn’t gain any confidence that NASH was a top priority anymore," Steven Seedhouse, an analyst at Raymond James, wrote in an Oct. 24 note to clients.
"Frankly, given we think ATLAS data are going to be negative, this strikes us as an indication Gilead will be dialing back investment in near-term and may wait to see how things play out for [Intercept] in the marketplace."
The second point of interest from the Glympse collaboration is its aim of identifying disease severity. While many pharmaceutical companies are working on NASH treatments, the consensus among them and healthcare providers is that payers will only cover NASH drugs for patients with the most advanced liver damage.
Yet it's unclear how many patients have that level of damage. The standard way to diagnose NASH is through liver biopsy — a procedure that is often painful, expensive and detested by both patients and physicians. According to a meta-analysis published in 2015, only about 15% of NASH patients were at the two highest levels of liver fibrosis.
With millions of U.S. patients expected to have NASH, doctors and drugmakers are trying to find non-invasive alternatives to liver biopsy. Notably, Gilead has reported an analysis of screening data from ATLAS that showed a combination of two non-invasive tests accurately identified advanced fibrosis in more than 80% of patients.
Gilead's latest deal may therefore indicate it sees Glympse's biomarkers as an even better way of stratifying patients.
"By utilizing this innovative technology, we hope to better characterize this complex disease and improve our understanding of how our compounds impact disease progression," Mani Subramanian, Gilead's head of liver diseases, said in an Oct. 28 statement.
Gilead and Glympse didn't disclose financial terms of their deal. Even so, the big biotech has shown a willingness to bet on NASH drugs and technology. In April, it began working with Novo Nordisk to test combination therapies for the disease. That same month, Gilead and Insitro entered a research pact focused on using machine learning to find new NASH drugs.
Those deals came just several months after Gilead put more than $1.5 billion on the table for rights to three preclinical drug programs from Scholar Rock Holding Corp.
Gilead has invested in NASH and other disease areas such as immunology over the past year as its hepatitis C business continues to bottom out. While the company dominates the HIV drug market, it faces competition from big pharma rivals, including GlaxoSmithKline and Merck & Co.
Year to date, Gilead's share price has fallen almost 10%.