To make a long story short, Phase IIa means that the drug in question -- BMS-790052 -- is still in the early stages of testing. I wouldn't expect this drug to be approved for at least another three years.
Some trials, known as phase I studies are mainly tests of safety (although they may collect some minimal information on the treatment's usefulness). Other studies, known as phase II and phase III studies, collect lots of information about both safety and usefulness. A drug must clear through all three phases of development, in which lots of data are collected, before the sponsoring pharmaceutical company can petition the U.S. Food and Drug Administration for approval.
Phase II is, in effect, an exploratory phase of research -- this is the time for researchers to look for potential efficacy (which is clearly shown here), ferret out any key side effects and figure out which dose of the drug is the safest and most effective to use. A Phase IIb study will ultimately be conducted to refine the results of the Phase I and Phase IIa study results.
In Phase III -- and there will probably be at least two studies (one involving people starting hep C treatment for the first time and another in people who didn't respond well to treatment in the past), which can take a while to enroll, conduct, analyze and prepare for presentation. Phase III studies usually involves several hundred people to ensure the most accurate results.
Of course, there is a way to access these drugs before they're approved -- through clinical trials. To learn more about studies involving BMS's NS5a inhibitor, click here.
Tim Horn
farmgirl:
Santaris Releases Phase II Data Showing Its HCV Drug Is Well Tolerated, Effective
"showing that the drug is well tolerated and can trigger “continuous and prolonged” antiviral activity that extends beyond the time of active treatment."
Not sure exactly what it all means but sounds like it is moving in the right direction. Phase II is early I think so this one still has a long way to go.
tommyv:
Cyclophilin Inhibitor Alisporivir Shows Promise in Phase II Hep C Study