Brainstorm Health: Virta Health Exclusive, Drug Pricing Hearing, Vertex CRISPR Trial

An exclusive for you today—Virta Health, a digital health upstart that helps treat and prevent diabetes without the use of medication or surgery, is touting a new study showing the approach also holds promise for a common liver disease, Fortune has learned.

“These study results are particularly exciting because there are currently no drugs on the market to treat the condition,” Virta CEO Sami Inkinen told Fortune in an interview.

The condition is called nonalcoholic fatty liver disease (NAFLD) and involves a buildup of fatty tissue in the liver. Appproximately 30% to 40% of American adults have NAFLD, according to the National Institutes for Health (NIH) – a figure likely informed by the fact that people with obesity or type 2 diabetes are at significantly higher risk for the disorder.

Fat in the liver in and of itself doesn’t necessarily cause any symptoms. However, people with the more serious form of the disease, nonalcoholic steatohepatitis (NASH), can face extensive liver damage that can even progress to liver cancer.

Patients with NAFLD are usually just told to lose weight and maintain a healthy diet – and that’s where Virta comes in. The company’s platform consists of connected devices that collect biometric data such as weight and other markers and sends this data to medical experts who then tailor personalized diet and lifestyle suggestions to customers. Previous studies have shown that Virta’s technology doesn’t just show promise in preventing prediabetes from morphing into type 2 diabetes, but can actually reverse type 2 diabetes in patients who have used the all-digital system for at least a year.

The new research, a nonrandomized controlled study, shows similarly impressive results for type 2 diabetes patients who also have NAFLD. People who stuck with the Virta system for a year experienced 12% average weight loss and 60% reductions in liver fat scores, among other improvements in metabolic and cardiovascular risk factors.

“NAFLD is a silent liver disease because patients often do not experience symptoms until it has progressed to NASH, cirrhosis or liver failure,” said senior study author Dr. Naga Chalasani in a statement. “Because there are no approved [drugs] for NASH and diagnosing the coexistence of NAFLD is rarely pursued in the standard treatment approach for type 2 diabetes, it is encouraging to see the Virta’s Treatment effect on this common comorbidity.”

A number of major pharmaceutical companies have been pursuing experimental treatments for NASH, eyeing the massive market such a breakthrough treatment would have in the U.S. If Virta’s results hold true and can be replicated, it might beat them to the finish line as the first effective tool to fight the liver disease.

Read on for the day’s news.

DIGITAL HEALTH

FDA, Flatiron expand collaboration on bringing real world data to clinical trials. The Food and Drug Administration (FDA) is ramping up one of Commissioner Scott Gottlieb's pet projects—an effort to use "real world" data as a sort of surrogate information source in clinical trials (as opposed to recruiting active participants in a drug study). The collaboration is with Flatiron Health, the "smart" oncology-focused electronic health records vendor that was snatched up by drug giant Roche last year. The partnership was struck all the way back in 2016 but will now have a two-year extension focusing on data from the kinds of patient populations who are typically underrepresented in clinical trials. (Becker's Hospital Review)

Vertex, CRISPR Therapeutics reach gene-editing milestone. Rare drug maker Vertex Pharmaceuticals and gene editing firm CRISPR Therapeutics announced that they've treated the first patient with an experimental CRISPR/Cas9 treatment called CTX001, meant for patients with the rare blood disorder beta thalassemia. It's the first instance of a biopharma company-sponsored use of the technology in a human patient. "We have made tremendous progress with CTX001 and are pleased to announce that we’ve treated the first patient with beta thalassemia in this clinical study," said CRISPR Therapeutics CEO Samarth Kulkarni in a statement. "Treating the first patient in this study marks an important scientific and medical milestone and the beginning of our efforts to fully realize the promise of CRISPR/Cas9 therapies as a new class of potentially transformative medicines to treat serious diseases."

INDICATIONS

Congress stares down big pharma CEOs. An epic Senate committee hearing met a compendium of Big Pharma CEOs on Tuesday. The chief executives of Merck, Pfizer, AstraZeneca, AbbVie, the chairman of Johnson & Johnson's drug making unit, and others faced the ire of Senators from both sides of the aisle. The conversation was long and heavy—and, at some points at least, surprisingly substantive. It's unclear that any changes will come to the industry along the lines of the backlash to Big Tobacco in the 90s, which Sen. Ron Wyden specifically mentioned during his opening statement. But the CEOs themselves did offer up some suggestions for what they think might be valuable reforms (these, of course, also speak to the industry's priorities and self-interest). There's too much packed in to spell out in just one blurb... More on this soon.

THE BIG PICTURE

States grapple with measles outbreak options. In the wake of a multi-state measles outbreak spurred by the anti-vaxxer movement, a number of states' public health officials are mulling options to prevent similar outbreaks in the future. In Iowa, New Jersey, and Vermont, lawmakers are considering whether or not to issue a blanket ban on vaccine exemptions other than for medically necessary reasons; others are considering various measures from eliminating person or philosophical exemptions while leaving religious exemptions in place. (The Hill)

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