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About half of patients had headaches, and about one fourth dropped out of the earlier studies, Randle says. That problem has been addressed by changing the trial design to allow the drug to be taken with food, and allowing an over-the-counter pain med in the ongoing study for headaches. A new formulation of the drug is designed to slow down the absorption of dipyridamole, to stop it from causing headaches, Randle says. The dropout rate in the ongoing study has fallen considerably, he says.
Another change: dosing. Earlier studies required that patients take multiple pills of prednisolone and dipyridamole twice daily, while the ongoing Comet-1 study combines them into a single capsule that is taken twice daily. The company is now working on another formula for a capsule that could allow the medicine to be taken once daily. CombinatoRx CEO Alexis Borisy (an Xconomist) likes to call these various formulations “Good, Better, and Best,” says Nugent.
If the Comet trial succeeds in October, then CombinatoRx will rev up talks with big drugmaker partners who can help it run the pivotal clinical trials needed to get Synavive approved by the FDA, Randle says. CombinatoRx, with just 160 employees, doesn’t have the capital or human resources to run such trials, which require thousands of patients to demonstrate safety. The partner will also have to have marketing muscle, and an interest in extending Synavive’s reach to patients with rheumatoid arthritis, asthma, and chronic obstructive pulmonary disease, Nugent says. Pricing of the drug will probably be similar to the Cox-2 inhibitors, like Celebrex, at about $1,500 to $1,800 a year, per patient, Randle says.
One irritating aspect of this trial is the timing. The results are coming out past the deadline for the American College of Rheumatology meeting in San Francisco, and the next big meeting on the calendar where CombinatoRx wants to present the data is The European League Against Rheumatism, which isn’t coming until June. So that means that CombinatoRx could release some of the basic results in a press release to investors in October, but we may all have to wait nine months for the full details to come out in public. I guess we’ll have to speculate how good the data really is by reading between the lines in the coming months, if and when a big drugmaker writes CombinatoRx a big check for a piece of Synavive.
If Synavive flames out, then CombinatoRx will have to turn to three other drugs in early-stage clinical trials for dermatology conditions and diabetes. Not all biotechs have that many fallback options, so life will go on at CombinatoRx. But like Nugent says, it would certainly give investors, employees, and patients a reason to down a tequila shot or two.