first quarter of 2013, after which time Eleven will move directly into the pivotal trials it will need to complete to gain FDA approval. “We’ve had these discussions with the FDA already,” she says. “We’re so confident in the mechanism of this drug that we believe we’ll be able to be very aggressive in our trial program.”
Celniker is also confident the FDA won’t require head-to-head trials against Allergan’s drug because it is not approved to treat pain. “There is no drug on the market that does what the agency is requiring our drug to do,” she says.
Eleven plans to retain full marketing rights to EBI-005 in the U.S. but to look for development partners overseas, particularly in Japan, the second-largest market for dry-eye treatments, Celniker says. “Strategically having relationships in Japan is very important because they’ve had two or three products approved there, and they understand the disease as well as people in the United States do,” she says.
Celniker says the expanded Series A will also help support Eleven’s pipeline, which includes two molecules that target different IL pathways, as well as a drug that works against myostatin, a protein that can contribute to muscle-wasting diseases. All emanated from Eleven’s technology platform for rationally designing drugs. “It’s really important now to be able design drugs in a fast and efficient way,” Celniker says. “We think EBI-005 is a great flagship for our general platform.”
