Eleven Biotherapeutics, Inc. EBIO announced disappointing top-line results and reported that its lead pipeline candidate, isunakinra (EBI-005), failed to achieve the primary endpoint in a phase III study.
The multi-center, double-masked, randomized, vehicle controlled study (n=258) was conducted to evaluate the safety and efficacy of isunakinra for up to four weeks in patients with moderate-to-severe allergic conjunctivitis in an environmental setting.
Results from the study revealed no statistically significant differences between the isunakinra-treated group and the vehicle control group on the primary endpoint of ocular itching or on any secondary endpoints. However, isunakinra was found to be well tolerated with 94% of the patients completing the study and no serious adverse events being reported during the course of the study.
Based on disappointing phase III study results, Eleven Biotherapeutics does not see an immediate path ahead for the candidate in allergic conjunctivitis. Instead, the company plans to focus on the development of EBI-031 for indications including diabetic macular edema and uveitis. The company intends to submit an investigational new drug application to the FDA for EBI-031 in diabetic macular edema in the first half of 2016.
Eleven Biotherapeutics stated in its press release that owing to the outcome of the study, the company is now required to fund a cash collateral account with Silicon Valley Bank of about $15.1 million, representing the outstanding amounts under its loan agreement with the same. As of Dec 31, 2015, Eleven Biotherapeutics had about $36.1 million of cash and cash equivalents and the company expects its unrestricted cash and cash equivalents to fund its operating plans into the fourth quarter of 2016.
Last May, shares of the company nosedived after isunakinra failed in the first pivotal phase III study (OASIS) in patients with moderate-to-severe dry eye disease. The company had decided against advancing isunakinra in a second phase III study for the dry eye disease indication.
Meanwhile, the company intends to provide an update on its corporate strategy later this quarter on the 2015 year-end financial results conference call.
Eleven Biotherapeutics is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Acorda Therapeutics, Inc. ACOR, Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT. All three hold a Zacks Rank #1 (Strong Buy).
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