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more serious effects like convulsions, respiratory depression, coma, and death, according to the Xyrem prescribing information.
On a practical level, it’s also not ideal to treat a sleep disorder by asking people to wake up in the middle of a normal 7-8 hour sleep cycle.
Concert hopes to be in position to file an application to the FDA to begin clinical trials of the new drug later this year. But because of the history of abuse with the compound, Concert may have to clear some extra hurdles with the Drug Enforcement Administration before it goes ahead in clinical trials, Tung says.
The new program helps provide a little more diversification to Concert’s pipeline of drug candidates. The company, founded in 2006, has another partnership with Aliso Viejo, CA-based Avanir Pharmaceuticals (NASDAQ: AVNR) to make a deuterium-modified form of dextromethorphan as a treatment for neurological and psychiatric disorders. Between the new Jazz partnership, the Avanir deal, and the previous collaboration with GlaxoSmithKline, Concert has been able to support its R&D shop without any new equity capital since 2008, Tung says.
While those deals are enough to pay most of the bills, the truly big event at Concert is still about six months away. The company recently announced it completed enrollment of a mid-stage clinical trial of CTP-499, its lead drug candidate for diabetic nephropathy, a type of kidney damage that people get with diabetes. This trial has randomly assigned 182 patients to get either the new Concert drug or a placebo.
If that drug hits its goal of reducing a sign of kidney damage in the urine after 24 weeks, then Concert will take on a different profile as a company. It still retains 100 percent ownership of CTP-499, although if the data are positive from this Phase II trial, it will likely seek a partner to help it take the compound all the way through the third and final phase of clinical trials normally required for FDA approval.
As the diabetes epidemic continues to grow, a number of competitors have been pursuing treatments for diabetic nephropathy, including Mountain View, CA-based ChemoCentryx (NASDAQ: CCXI), as well as New York-based Pfizer (NYSE: PFE) and Eli Lilly (NASDAQ: LLY).
“We are on the cusp of being a Phase II-completed company, which will put us into a different kind of situation,” Tung says. “We have a lot going on, with first-in-class compounds, and best-in-class compounds. We’re excited about the technology.”