Resolvyx Pharmaceuticals, the company that develops derivatives from omega-3 fish oils into new drugs, is announcing today that the first therapy from this class passed its first clinical trial, helping alleviate symptoms for patients with chronic dry eye.
This was a big hurdle for Bedford, MA-based Resolvyx to clear, partly because the company set the initial bar unusually high. Most initial clinical trials enroll only a dozen or so patients, assess safety at a number of low doses, then start thinking about effectiveness. But Resolvyx cut to the chase. It is reporting today that its proprietary eye drop was able to achieve a statistically significant reduction in the dryness, stinging, burning, and grittiness sensations in a trial of 232 patients who were randomly assigned to get the drug or a placebo. There were no serious side effects.
This is certainly a big step for Resolvyx, because it provides some validation to the company’s claim that its class of compounds, called resolvins, can have potent anti-inflammatory effects. Resolvyx plans to develop oral pill formulas that can be used broadly in common inflammatory diseases like asthma or inflammatory bowel disease. While dry eye doesn’t sound nearly as serious as those conditions, it is one of the most common eye conditions treated by doctors, and is estimated to affect 25 million to 30 million people in the U.S..
“There is an urgent need for new treatment options in dry eye and the results of this Phase 2 study are as strong as any I have seen,” said Stephen Pflugfelder, an expert in dry eye at Baylor College of Medicine, in a company statement. “Based both on these clinical results and on its unique mode of action, I am confident that RX-10045 can be an important new treatment.”
Full details haven’t yet been presented in a peer-reviewed journal, although the results are expected to be presented at the Association for Research in Vision and Opthalmology meeting next year, the company says.
For the biostatistical sticklers out there, don’t worry, I had a chance to comb through the details with Resolvyx’s chief operating officer James Nichols. But for those who just want the gist, here goes: Resolvyx can’t go quite so far as to say this was an absolute grand slam, but the results are certainly good enough to go ahead with final stage clinical trials, estimated to begin in the first half of 2010. It’s also enticing enough that Resolvyx will now hit the fundraising trail to seek another round from investors, and discuss partnership possibilities with big drugmakers, Nichols says.
So what about the details has gotten Resolvyx so excited? The trial looked at
