Resolvyx Pharmaceuticals is eying the ophthalmic market. The Bedford, MA-based biotech firm plans to announce today that the first human clinical tests of its resolvins—compounds with anti-inflammatory properties that occur naturally in fish oil—will be in patients with dry eye syndrome.
Mind you, many initial clinical trials are done with small pools of 40 or so healthy volunteers to test the safety of drugs. In Resolvyx’s planned trial, however, the firm plans to enroll 200 patients with dry eye to study not only the safety of a resolvin compound, dubbed RX-10045, but its effectiveness at various doses, CEO Paul Rubin says. The so-called Phase 1/2 trial, slated to begin before the end of the year, could also provide data to support later trials in other eye disorders such as age-related macular degeneration.
Luke wrote about Resolvyx and its strategy to commercialize resolvins in July, when company officials talked more about use of the compounds in inflammatory disorders such as asthma and rheumatoid arthritis. While the company still plans to begin an initial clinical trial for asthma with a separate resolvin compound by mid-2009, Rubin told me why his company chose to pursue eye disorders first.
“I think it’s a little bit easier to do the eye because people aren’t systemically affected by the drug,” Rubin says. “The thing about ophthalmology is you can actually do your first clinical trials with patients rather than just [healthy] volunteers. If the findings are positive, then we have obviously accelerated the timeline for development.”
It’s not totally uncommon for drug developers to test novel compounds in peoples’ eyes before trying them inside the body. In fact, some of the earliest clinical trials of RNA-interference drugs have been for eye disorders, such as San Francisco-based Sirna Therapeutics’ early trial to develop the treatments for age-related macular degeneration.
The market for dry eye products is huge as well. Resolvyx says that there are between 25 million and 30 million Americans with dry eye syndrome. And in animal tests, the company found that one of the benefits of its resolvin treatment was it prevented loss of mucus-secreting cells that help to keep our eyes lubricated.