of success in clinical trials.
“We look at the entire molecule, understand what’s responsible for its function, and optimize it,” Celniker says. “Getting the structure/target relationship right, seeing how the molecule interacts with the target is important. That’s the key to knowing which part of the toolkit to use.”
Eleven has apparently been moving fast in the early going, because Celniker says she expects the company to enter its first clinical trial by the second half of 2012. The protein drug candidate is being developed as a treatment for dry eye and other topical inflammatory conditions like allergies or pink eye (conjunctivitis.) Celniker isn’t saying what target Eleven is aiming this drug at, but another compound has proven it’s a valid target, which mitigates the risk to Eleven, she says. The protein can be easily formulated into an eye drop; going after eye conditions means Eleven can follow a reasonably fast clinical development plan; and it’s an area of expertise of one of the scientific founders, Reza Dana of the Massachusetts Eye & Ear Infirmary. Since another compound has already been in the clinic, Eleven has a good idea of the dosing and dosing schedule that its drug will need to succeed, Celniker says.
“We don’t have to do so much trial and error,” she says. “We think we can rapidly move into pivotal trials.”
Eleven will consider signing up a partner to help with its lead drug, and it is working to build up a pipeline of other drug candidates, Celniker says. So the goal here is to not be a one-hit wonder, and to have some staying power in the pharma business.
“We know how important proteins are to the portfolios of Big Pharma and Big Biotech,” Celniker says. “People put a stake in the ground to increase their portfolios in biologics several years ago. Eleven is really a company that is bringing an innovative approach.”