Pharma

BioCryst invests $5M into pipeline that includes gout, hepatitis C drugs

BioCryst Pharmaceuticals (NASDAQ:BCRX) got its hands on some big dollars in the first three months of 2011, securing $55 million from a federal contract for its experimental flu treatment peramivir and net proceeds of $23 million through a deal with a Japanese partner. But here’s a number that might have slipped under the radar — […]

BioCryst Pharmaceuticals (NASDAQ:BCRX) got its hands on some big dollars in the first three months of 2011, securing $55 million from a federal contract for its experimental flu treatment peramivir and net proceeds of $23 million through a deal with a Japanese partner.

But here’s a number that might have slipped under the radar — $5 million. That’s how much Durham, North Carolina-based BioCryst has boosted spending for two other pipeline programs, one a mid-stage drug candidate treating  gout and the other, a preclinical compound for hepatitis C. The $5 million is a small figure compared to the other two major financial events of the quarter. But BioCryst is betting that this investment will pay off big.

The experimental gout drug is called BCX4208. The compound is already in mid-stage clinical trials, but BioCryst is directing part of that $5 million investment for further studies of the compound in patients who do not respond to allopurinol, a drug used to reduce the levels of uric acid produced by the body in patients who have gout. This larger study of 250 patients is enrolling patients now and will evaluate the drug in patients over the course of three months. An earlier trial studied the drug over just three weeks.

There’s more to this trial than just forming a larger study over a longer period of time. CEO Jon Stonehouse explained during the company’s quarterly conference call that the trial will also study patients’ immune systems after three months on BCX4208. BioCryst wants to find out if the immune system remains strong enough to produce antibodies after being on the treatment. BioCryst will also be looking for possible drug interactions because gout patients can be on heart or diabetes medications. The company believes BCX4208 won’t have interactions. With the study, they’ll have that data back up the claim. They’ll also have data to help BCX4208 stand out from other drugs.

“That whole package, we believe, is very robust and will give us a good sense of the safety, efficacy and differentiation of this molecule,” Stonehouse said.

The rest of that $5 million investment will be directed toward BCX5191, a compound discovered by BioCryst. Based on the compound’s development in preclinical studies, BioCryst believes it can be developed into an effective hepatitis C drug with once-a-day dosing. Analysts questioned BioCryst on BCX5191 given that there are a lot of hepatitis C drug candidates already in development. But BioCryst Chief Medical Officer Dr. William Sheridan said that most of the hepatitis C drug candidates haven’t advanced. Moreover, BCX5191 has shown unusual promise in the preclinical stage. The compound is permeable to cells and so far isn’t toxic to cells. That’s important because the current hepatitis C treatments have serious side effects. The compound also converts to an active form in human target cells and stays in an active form for a long time.

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“Every single thing about this molecule, so far, it has passed every test with flying colors,” Sheridan said. “That’s not necessarily normal. Lots of molecules come into development with one or two or three dings on their scorecard. That’s not the case here. It hasn’t got a single ding.”

The hepatitis C opportunity is huge. An estimated 170 million people worldwide have the disease. Stonehouse believes BCX5191 will be of interest to large pharmaceutical companies and BioCryst will seek  partners. Stonehouse said that if BCX5191 can move through toxicity studies and into phase 1 clinical trials, it will be an attractive asset.

“That’s part  of the reason we prioritized it so high and decided to make the investment,” he said. “We think we can create value off of this molecule in the not-too-distant future.”

Depending on the results of the additional studies, BioCryst expects to engage with the U.S. Food and Drug Administration in 2012 about both BCX4208 and BCX5191. BCX4208, the gout treatment, will be the subject of end-of-phase 2 discussions in the first half of 2012.  BCX5191 is targeted for an investigational new drug application by the end of that year.