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it needs to be kept refrigerated in warm environments, making it a hassle for patients to travel with it and take it to work. It’s also an extra co-pay for patients, and can cause some nausea and increases in blood lipids, although he acknowledged the drug is “reasonably safe.”
Convenience might sound like something nice for a marketing campaign but trivial in the medical sense, but that’s not the case with HIV. Since the virus has such crafty ability to mutate, patients need to stay on their cocktail regimens on a consistent basis, and if they don’t, they are potentially creating an opportunity for the virus to flourish and develop resistance to treatment.
While making drugs more convenient to take is absolutely part of the long-range strategy of Concert, the company still has a really long way to go to prove this idea. This Phase 1 clinical trial will enroll healthy volunteers who will get multiple escalating doses to test the safety and tolerability of the product. The trial will also look to see if the drug can maintain concentrations in the bloodstream that are good enough to hold the virus in check with a once-daily dose, when combined with other drugs. Patients will be randomly assigned to get the Concert drug or a placebo for 14 days.
After the Phase I trials are finished, GlaxoSmithKline will have the option to take an exclusive, worldwide license to develop and commercialize the Concert drug.
It’s still too early to say whether Glaxo will want that option, or whether Concert will be on its own to find another partner for the HIV drug. But Tung says he likes the fact that Glaxo and Pfizer have decided to pool their HIV efforts in a joint venture to better compete with Gilead. Inside a joint venture with its own management team, the Concert program is likely to get more attention than it would as one of “a million other things” Glaxo has in its development portfolio, Tung says.
“This is great for us,” Tung says. “This drug is absolutely our world. We’ve got to make it work for us, for patients, and partners.”
Plus, while $12 million may not be much to GlaxoSmithKline, it’s a hefty boost for Concert and its team of 47 employees. The latest boost means the company now has more than two years of operating cash in the bank, Tung says.