June 13, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Struggling Eleven Biotherapeutics may have finally caught a break. The company struck a $270 million deal with pharma giant Roche to develop Eleven’s experimental EBI-031 treatment for eye-related diseases, such as diabetic macular edema and uveitis.
As a result, have soared this morning, hitting a high of $3.90 per share as of 9:35 a.m. Currently the stock is up more than 51 percent this morning, trading at $2.79 per share.
EBI-031 is a humanized monoclonal antibody that binds Interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling. EBI-031 was designed for intravitreal delivery using Eleven Biotherapeutics’ AMP-Rx platform. The drug blocks both free IL-6 and IL-6 complexed to the soluble IL-6 receptor.
Under the agreement, Eleven will be entitled to an upfront payment of $7.5 million, along with potential future milestone payments of up to $262.5 million. The first potential future milestone payment of $22.5 million, is subject to the effectiveness of an investigational new drug application for EBI-031, according to a statement issued by Eleven Biotherapeutics. The payment is time-related. If the IND becomes effective before Sept. 15, the company will receive the $22 million, but Eleven will lose $2 million if the IND becomes effective after Sept. 15, the company said. Eleven Biotherapeutics submitted the IND this morning to the U.S. Food and Drug Administration, Abbie Celniker, Eleven’s president and chief executive officer said in a statement.
“We are pleased to see Roche poised to further develop this potent IL-6 blocker for the potential benefit of patients. As previously announced, we also continue to evaluate additional strategic alternatives with a goal to maximize shareholder value,” Celniker said.
For the past year, Eleven Biotherapeutics has struggled with the failure of two experimental therapies. On Jan. 10, the company announced that its Phase III clinical trial of EBI-005 (isunakinra) for severe allergic conjunctivitis did not meet its primary endpoint. That was the second time EBI-005 failed to live up to expectations. In May 2015, the company reported that EBI-005, this time being studied for the treatment of moderate to severe dry eye disease, failed to prevent damage to the cornea or reduce eye pain in comparison to the control group.
With its failed drug trials, Eleven Biotherapeutics’ stock has struggled, to say the least. Since the January failure of EBI-005, shares of Eleven have struggled to rise above $1 per share, earning the threat of delisting from Nasdaq on March 3. The notice was issued after the stock fell below $1 per share and did not meet the $5,000,000 minimum stockholders’ equity requirement.
