Tags: Diabetes | Obesity | fatty liver | diabetes | drugs | NASH

Skyrocketing Rates of Fatty Liver Disease Spur Drug Search

Friday, 07 November 2014 01:17 PM

Next to Alice Gorman’s bed is a small suitcase packed with clothes and a fully charged mobile phone she carries wherever she goes. The news she’s waiting for: a donated liver that matches her blood type.
Gorman isn’t an alcoholic, an assumption nurses and emergency room doctors have made over the years when the 51-year-old Scottish woman tells them she has fatty liver disease. Her condition is non-alcoholic steatohepatitis, or NASH, which is primarily caused by obesity and diabetes, and can go undetected for decades.
Awareness of fatty liver disease that isn’t caused by drinking is scant, even as it affects a fifth of the global population and up to 70 percent of people with type 2 diabetes. NASH is an advanced form that can lead to cirrhosis, where the liver hardens and stops working properly. For Gorman, that meant a near-death episode of vomiting blood, trips to emergency rooms and a decision by doctors in September that she needs a new liver.
“I was quite shell-shocked,” Gorman, a manager at a telecommunications company, said in an interview. “But I’ve come to terms with it. My bags are packed, and I’m just waiting for the phone call.”
NASH is on track to become the most frequent cause of liver transplantation by 2025, as rates of obesity and diabetes rise globally, according to Bloomberg Intelligence. Biotechnology companies such as Intercept Pharmaceuticals Inc. (ICPT), Genfit and Gilead Sciences Inc. (GILD) are racing to develop the first treatments for NASH, an untapped market that Deutsche Bank AG says may reach $40 billion globally.
Intercept’s publication today of a mid-stage study of its experimental NASH drug is the “most anticipated presentation in biotech for the year,” according to Andrew Berens, an analyst at FBR Capital Markets & Co. in New York.
Patients who took Intercept’s obeticholic acid showed an improvement in fibrosis, or scarring of the liver, which suggests the drug may help prevent progression to cirrhosis, according to a paper published in the Lancet journal.
Even so, the treatment elevated levels of bad cholesterol and its “long-term safety requires further clarification,” the researchers said. The benefit to the liver from Intercept’s therapy was similar to that from treatment with vitamin E and pioglitazone, a diabetes drug.
Companies including Genfit and Galectin Therapeutics Inc. (GALT) will give presentations on NASH therapies at the American Association for the Study of Liver Diseases annual meeting, which starts today in Boston.
Investor Interest
Investor expectations are soaring for NASH treatments. New York-based Intercept’s shares more than tripled on Jan. 9 on promising trial results for its drug. The shares slipped as much as 13 percent in late trading yesterday after data from the latest study were released.
Genfit (GNFT)’s stock has more than quadrupled this year in Paris trading, while Galectin has dropped about 38 percent in New York on investor doubts about its trial results.
NASH can be undetected for years even when cirrhosis has occurred, and can also lead to symptoms such as confusion and disorientation, said Ewan Forrest, a liver specialist at Glasgow Royal Infirmary and Gorman’s physician.
“It can be quite devastating,” he said in a phone interview. “When I see patients who’ve been diagnosed, quite a lot of the consultation is focused on dealing with their shock and surprise.”
Christmas Eve
Gorman’s diagnosis came on Christmas Eve in 2004. The day before, she phoned her doctor with flu symptoms. She was sent to the hospital because the doctor had identified enlarged veins in her digestive tract earlier that year, and suspected she was bleeding internally.
In the early hours of the following morning, she started vomiting brown blood, which meant it was old. As the nurses cleaned her up, the vomiting resumed, and this time it was red.
“Had I not been in hospital, I would have died,” she said. “They told my family that they weren’t sure I would make it.”
A biopsy confirmed she had non-alcoholic cirrhosis of the liver. Every six weeks thereafter, she visited the hospital for endoscopies to check for additional enlarged veins, getting them banded if they appeared. That continued for 9 years.
Forrest took over as Gorman’s doctor in February when she was rushed to the emergency room after vomiting blood while at work. That led to a month-long hospital stay to treat her veins.
No Drugs
Diagnosed with diabetes in 1999, Gorman has been taking metformin and gliclazide, common medicines for the condition. As no drugs are available for NASH, the standard therapies are better diet, exercise and avoiding alcohol. Cirrhosis leads to excess fluid in the stomach, which squashes the diaphragm and lungs and makes it difficult to walk and breathe, Gorman said.
When the therapies were no longer improving her condition, doctors placed Gorman on the transplant list. There is a good chance a suitable donor will be located within the next four months, Forrest said.
“I caught her at the tipping point of her condition,” Forrest said. “We saw that standard medical therapy wasn’t going to resolve the situation quickly so we had to consider a more radical solution.”
As a disease that can progress silently, NASH often escapes primary-care physicians, and diagnosis isn’t straightforward, Forrest said.
Diagnosis Methods
No specific blood tests are currently available for NASH. Fatty liver disease is usually first suspected through liver function tests or ultrasound scans done as part of routine health checks or for unrelated reasons, Forrest said. If other forms of liver disease are excluded by blood tests and ultrasounds, elastography imaging is used to measure stiffness of the organ to see if it’s scarred. People with simple fatty liver won’t show such damage. Biopsies are also used for diagnosis.
Awareness of the risks of the disease, until recently dismissed even by diabetes specialists, is gradually rising among primary doctors, Forrest said. As treatments for diabetes and associated ailments have improved, patients are living longer, allowing more time for liver conditions to appear, he said.
In July, Forrest and Naveed Sattar, a professor of metabolic medicine at the University of Glasgow, published guidelines for diagnosing fatty liver disease to aid physicians. Non-alcoholic fatty liver disease is now more common than the alcoholic version because of the obesity epidemic, they said.
Based on the shock he encounters among patients, awareness is much lower among the public, Forrest said.
Gorman agrees.
“It would be useful for this disease to have a higher profile and to have people understand that cirrhosis isn’t just about people who drink,” she said. “It’s about people who don’t eat healthily and eat too much fat. Lifestyle has a lot to do with it.”

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Next to Alice Gorman's bed is a small suitcase packed with clothes and a fully charged mobile phone she carries wherever she goes. The news she's waiting for: a donated liver that matches her blood type. Gorman isn't an alcoholic, an assumption nurses and emergency room...
fatty liver, diabetes, drugs, NASH
Friday, 07 November 2014 01:17 PM
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