Eleven Biotherapeutics is using its proprietary AMP-Rx protein-engineering platform to develop agents for more effective treatment of allergic conjunctivitis as well as to investigate new treatments for patients with diabetic macular edema (DME) who do not respond to anti-VEGF therapy.
In October, the company had completed enrollment in its double-masked, randomized, vehicle-controlled Phase III pivotal trial of the IL-6 antibody isunakinra (EBI-005) for the treatment of moderate to severe conjunctivitis, conditions that afflict approximately 5.8 million people altogether, President and CEO Abbie C. Celniker, PhD, reported at OIS@AAO.
The Phase II trial showed a statistically significant difference in relieving itching between isunakinra and the vehicle agent, Dr. Celniker said. Eleven Biotherapeutics anticipates readout from the Phase III trial of 258 patients in first-quarter 2016. The primary endpoint will be ocular itching, with tearing, nasal symptoms, and conjunctival redness as secondary markers.
Eleven Biotherapeutics has also focused on DME and the 25% of patients who derive no benefit from anti-VEGF therapies. The investigative agent EBI-031, which, like isunakinra, also acts to block IL-6, and has been shown to blockade 95% of IL-6 for at least 120 days in animal models, Dr. Celniker said. “This should translate into a much reduced frequency of administration relative to the VEGF antibodies and blockers in DME and possibly give us a frequency of administration of not more than every three months,” she said.
Dr. Celniker projected Eleven Biotherapeutics would file an Investigational New Drug application for EBI-031 in the first half of 2016.
Abbie C. Celniker, PhD
Dr. Celniker brings more than 20 years of proven protein therapeutic expertise to Eleven Biotherapeutics. Prior to joining Eleven, Abbie was CEO of Taligen Therapeutics, which was acquired by Alexion Pharmaceuticals.