about what needed to be done. After a quick pilot study, it was November when MediQuest started screening patients into this new pivotal study.
Screening is important, because researchers need to weed out all the patients with mild symptoms of Raynaud’s, who aren’t likely to be good subjects to show the real difference between drug and placebo. MediQuest needs about 60 good candidates for study, who will then be randomly assigned to the drug or the control group.
The way this works is actually pretty simple. Patient walks into the cold room, applies drug or placebo, and stays in there for 15 minutes. Patient is then asked to rank their pain on a standard scale of 0 to 10. When it’s over, they’re compensated with a trip to a warming room.
The FDA has agreed that if MediQuest can show an average of a 1.8-point improvement in pain scores, that would be medically meaningful, Dechow says. That means if placebo patients report their average pain score is a 6.0, then the drug group would have to average a 4.2 score or better.
It’s not a stretch to say the fate of the company is riding on this trial. MediQuest cut half its staff, trimming its workforce to 15 people, after the FDA rejection in October 2008. MediQuest raised $23 million in this same quarter a year ago to finish its development plan, which represented some new money and a conversion of old debt into equity, Dechow says. But that won’t last forever. The company is continuing to raise money from angels and venture capitalists to make sure it can complete the study, Dechow says.
Most importantly, MediQuest is trying to work the business development front hard, by having talks with five potential partners who are weighing possibilities of buying the drug, or the company, Dechow says. Some talks are designed to strike such a deal before the data is available, after the data comes out, or after FDA grants approval, Dechow says. Obviously, the further along the drug progresses on that timeline, the higher the price would go.
I can’t really imagine anyone would pay much to buy the company before at least seeing the results from this cold room study. No study like this has been done before, so there’s not much of a basis to handicap it. And even if the data is promising, there will be doubts about just how big a market exists to treat a disease that is considered mild 80 percent of the time. But that’s all part of the risk inherent to drug development. Dechow sure seems to relish it, and is looking forward to his precious results.
“We are pioneers,” he says.
