Dr. Laurent Fischer and Dr. Eckard Weber co-founded the San Diego biotech Ocera Therapeutics in 2005 with the license to a Japanese drug used to treat chronic kidney disease. Fischer said the oral adsorbent acts like a sponge, binding to toxins in the gut and helping to remove them. Ocera tested the drug on a number of diseases and found it was successful on a few, including irritable bowel syndrome and cirrhosis of the liver.
This week Ocera completed enrollment for an eight-week study of the effectiveness of the drug on a little-known condition called mild hepatic encephalopathy, a state of mental confusion experienced by more than half of people with cirrhosis (a disease commonly caused by Hepatitis C, alcohol abuse, obesity or diabetes).
“There was a study that put patients with liver cirrhosis through a driving simulation, and it showed that patients very frequently crossed the center line,” he said. “It’s also known that these patients have a lack of ability to concentrate, and are sleepy during the day, and they often lose their jobs and sometimes fall down and need be hospitalized. There is a very significant decrease in the quality of their life.”
We talked with Fischer about Ocera’s work with this drug, called AST-120 or ASTUTE, other ways biotechs can find funding now that venture capitalism has slowed, and why San Diego is a better place to develop drugs than Switzerland.
Ocera completed enrollment for the study ahead of schedule. How were you able to?
There has never been a study conducted that offered a diagnosis and treatment for this disease. We were able to recruit participants ahead of time because there is truly an unmet medical need. Both patients and physicians know this disease is a problem, so when we’re offering the potential to be diagnosed and treated, they realize it’s a good opportunity.
Why has there been so little treatment for this disease before?
People didn’t study mild hepatic encephalopathy because there was no reliable way to diagnose it. Only last year were guidelines issued to properly diagnose the disease.
This week the FDA recommended approval for an antibiotic that also treats hepatic encephalopathy. Is this good news for you?
Absolutely. It’s very important to have the FDA recognize the importance of a disease that’s not treated, or whose treatment is sub-optimum. The population they were looking at is more severely debilitated, and have already had prior episodes of acute hepatic encephalopathy, so it’s a much different population. But I’m very pleased to see that the FDA had a positive recommendation, because there hasn’t been a new drug in over 30 years. I hope they get approval.
Before starting Ocera, you were responsible for the launch of Invirase and Sustiva, some of the first drugs to treat or prevent viral infections like HIV and Hepatitis C. How did you go from those diseases to liver disease?
Patients with HIV can also be co-infected with Hepatitis C, unfortunately. Very frequently this leads to liver cirrhosis — even with new advances in treatment — since most patients are not symptomatic and not diagnosed until the damage to the liver is irreversible. I’ve always been interested in ways to treat and prevent the complications that come from diseases like Hepatitis C, and hepatic encephalopathy is what I’m focused on now.
Ocera has raised $62 million since its start in 2005, mostly from venture capital. What enabled you to find this funding?
Our ability to demonstrate to investors that we could identify prominent applications and opportunities for drugs, and to complete studies on schedule or ahead of schedule. This creates the type of value venture capitalists are looking for. Track record of course helps.
Are you planning on issuing an initial public offering?
The most important aspect of what we do is expedited drug delivery to the market and patients who need new treatments, and that will require additional financing. We are in active discussion with financers and investors, and are considering all options that will allow our company to move forward, including partnerships with pharmaceutical companies.
So an IPO would be one of those options?
It’s one of the avenues we’re pursuing, but we understand the IPO market is very challenging so it’s one of the options. We are a company that’s productive with a drug that has a well-established safety profile and is marketed in Japan, so we think we would have a positive reception among public investors.
You have an undergraduate degree from the University of Geneva and a medical degree from the Geneva Medical School. Are you from Switzerland?
I grew up in Switzerland, and did practice for a time at the University Hospital in Geneva, but I ended up liking the U.S. As it offers more opportunities. It’s the best place for drug development and start-up companies.
Why?
The U.S., and particularly San Diego, has a combination of three things that are critical: academic institutions, people with a track record of developing drugs who understand drug development well, and venture capitalists willing to fund these companies. This cluster allows biotechs to be successful.
Now that enrollment is complete, what’s next for your trial of AST-120?
The study will last eight weeks, so we will have data from the study in the middle of the summer. The plan after that is to meet with the FDA, and then start final pivotal trials in the fourth quarter of this year. We hope to file a new drug application in 2012, and based on the unmet need we hope to have an expedited review. The goal is to get the drug to market as soon as possible, hopefully in 2013.
— CLAIRE TRAGESER