Blow for Eleven Biotherapeutics as eye drug fails in late-stage trial
pharmafile | January 18, 2016 | News story | Research and Development, Sales and Marketing | Eleven Biotherapeutics, allergic conjunctivitis, isunakinra
A study by Eleven Biotherapeutics to prove the clinical value of its eye drug isunakinra has flopped, after the drug failed to help people with allergic conjunctivitis.
Shares in the company fell dramatically when the biotech company, based in Cambridge, Massachusetts, announced its Phase III study of the IL-1 receptor inhibitor, found no statistically significant benefits.
Eleven Biotherapeutics specialises in discovering and developing protein therapeutics to treat diseases of the eye, and has invested heavily in its lead drug candidate isunakinra- including drumming up financial support from external investors to back another trial after the drug failed in a late-stage study in people with dry eye disease.
In this trial, there were no statistically significant differences between the isunakinra-treated group and a control group on the primary endpoint of itching, or on any secondary endpoints.
The trial was designed to evaluate the safety and efficacy of isunakinra for up to four weeks in 258 patients with moderate to severe allergic conjunctivitis in an environmental setting. Shares in the company fell by 55% after it announced its top-line results.
Abbie Celniker, president and chief executive of Eleven Biotherapeutics, says: “We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis.”
Celniker revealed the company will now switch strategy, to the more advanced pipeline drug EBI-031, for diabetic macular oedema and uveitis, and submitted an investigational new drug application with the FDA in the first half of 2016.
Dr Michael Goldstein, chief medical officer of Eleven Biotherapeutics, comments: “Despite this outcome, we plan to continue to assess interleukin-1 genotyping in ocular surface diseases by evaluating data from patient subsets in this clinical trial identified to be high producers of IL-1.”
Lilian Anekwe
