Unfortunately, about 28% of Lomitapide patients can end up with high cholesterol in their liver as a result of taking the medication. Lomitapide was recently approved to treat children with very high cholesterol, an orphan indication. DUR-928 inhibits lipid absorption by inhibiting a protein called MTP, similar to a product called Lomitapide. They have bile acid analogues that they’ve modified that are able to inhibit bile acid and fatty acid synthesis DUR-928 can do that as well. Gilead is working with a company called Phenex. DUR-928 inhibits bile acid and fatty acid synthesis, very similar to what is seen with bile acid analogues that Intercept and Gilead are working on. DUR-928 inhibits the synthesis of triglycerides. There are five others enzymes in the cholesterol synthesis cascade. Statins inhibit the first enzyme in cholesterol synthesis. It inhibits cholesterol synthesis more broadly than statins.
DUR-928 is involved with energy and metabolism. The effects of DUR-928 are quite impressive, and I’ll go through some of those right now. Yet when we dose animals in various disease models, we see dramatic positive changes. In our animal toxicology studies, we’ve dosed to achieve 1000 times or more the natural plasma concentration and seen no changes at all. We’ve dosed the subjects in our Phase 1 trials with enough DUR-928 to achieve 100 to as much as 200 or 300 times normal plasma concentrations of DUR-928 and have seen no treatment related adverse events. In humans, you and I all walk around with just a few nanograms of this in our blood every day. We’ve been able to give a lot of this compound to normal animals and to normal people in Phase 1 and we’ve seen really no changes at all. Just to give a brief outline of what DUR-928 can mean for patients, first of all, from a class standpoint, it is a new class of steroid hormones that appears to have a very wide safety margin. DUR-928 is a major regulator of energy, lipids within our body, inflammation, and also cell-survival. DUR-928 is one of a family of endogenous molecules that have been discovered and that we are advancing. We actually have six patent families going forward for the program. We’ve kept very quiet - we think it’s a major discovery, and we wanted to make sure that we were able to lay down a strong patent position. It’s been a program we’re working on in the background while we’ve continued to develop our drug delivery pipeline of products.
DUR-928 is the lead molecule from our epigenomic regulator program, which is a program we’ve been working on in conjunction with Virginia Commonwealth University for about three and a half years. And can you talk about some of the exciting positive results there from DUR-928? Our epigenomic regulator program has discovered DUR-928, a naturally existing, endogenous hormone in the body, which was previously unknown, and it allows for a wonderful therapeutic opportunity for a number of diseases. This new program is an epigenomic regulator program, which has allowed DURECT to grow into a biotechnology company with a focus on new chemical entities. What’s really been transformative for Durect this year has been the announcement of a new program on March 2 nd of this year. We also have a number of earlier stage projects.
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The second late stage program is POSIDUR – we’re working on initiating a final Phase 3 trial to be able to resubmit the NDA. The first late stage program is REMOXY which is nearing resubmission projected for the first quarter of next year. Two of these programs are at the NDA stage and have received complete response letters. As a result we have a number of later-stage programs. For many years, the focus at DURECT has been to develop drugs using our drug delivery technology. To begin with, I should mention that I’ll make forward-looking statements during this interview, so I’d encourage all listeners to review our SEC filings carefully to understand the risks associated with our business. So starting off, please give us a history and overview of the company for some of our listeners there that didn’t catch our interview the last go-around.
The company trades on NASDAQ, ticker symbol is DRRX. Joining us today is Jim Brown, president and CEO of Durect Corporation. This is Juan Costello, senior analyst at the Wall Street Analyzer.
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