Cambridge, MA-based Eleven Biotherapeutics said today that it has expanded its Series A financing by $20 million, bringing the total raised in the funding round to $45 million. New investor JAFCO joined founding investors Third Rock Ventures and Flagship Ventures in their support of the company, which raised the first part of its Series A financing in February 2010.
The new cash will go towards the first human study of the company’s lead drug, EBI-005 to treat dry eye syndrome. That trial is slated to begin at the end of this year, says Abbie Celniker, CEO of Eleven. “We’ve completed most of our enabling work for the investigational new drug application, and we’re getting that ready for the FDA right now,” she says.
EBI-005 is what’s known as a “rationally designed” protein. That means that instead of cloning a naturally occurring protein or scouring libraries of known antibodies to find something that might be able to conquer dry eye, Eleven built its drug from the ground up to possess certain characteristics. First, it inhibits two types of interleukin-1 (IL-1) receptors that drive both the pain and inflammation associated with the disease. And the drug can penetrate the cornea, reside there for an extended period, and remain thermally stable—attributes that are key to getting anything to work properly in the eye.
In data from animal trials announced at an industry conference last night, EBI-005 was shown to be 10 times as potent at binding to IL-1 as anakinra (Kineret), an IL-1 blocker marketed by Amgen (NASDAQ: AMGN) to treat rheumatoid arthritis. It also proved to be more active than cyclosporine, which is the main ingredient of the $700-million-a-year dry-eye treatment marketed by Allergan (NYSE: AGN) under the brand name Restasis.
Celniker says Eleven’s drug will address some of the shortcomings of Allergan’s treatment. “Cyclosporine can quiet the inflammation but it can’t stop it,” she says. “It also has no impact on the pain associated with dry eye syndrome, which is what is really driving people to get treatment.”
As for Amgen’s drug kineret, Celniker says, it does block the two IL-1 receptors that spark pain and inflammation, but “not with a high enough affinity for what we would need in dry eye.”
To prove that EBI-005 has the right collection of characteristics, Eleven is planning an accelerated trial program, Celniker says. She expects that the first trial—which will focus mostly on safety—will be completed in the 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.”
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