Eleven's lead topical eye drug completes PhIa, enters PhIb trials

Eleven Biotherapeutics, a FierceBiotech's 2010 Fierce 15 company, has completed a Phase Ia trial and started a Phase Ib study for EBI-005 in patients with dry eye disease. EBI-005 is a topically delivered IL-1 (Interleukin-1) receptor inhibitor protein and is the lead product candidate from Eleven's AMP-Rx product engine.

In the Phase Ia trial, EBI-005 was safe and well tolerated, and showed early hints of improving both the signs and symptoms of dry eye disease. The 6-week Phase Ib trial, which will involve around 80 patients, is expected to complete in the first half of next year.

"Advancing the clinical development of EBI‐005, our most advanced product candidate, is a significant milestone for Eleven and an important validation of our growing pipeline of engineered biotherapeutics for ophthalmic disease," said Eleven CEO Abbie Celniker.

Dry eye disease is an area of unmet need, as many patients do not get full relief of the very irritating condition with currently available therapies. EBI‐005 acts by targeting IL-1 and blocking the cascade that causes dry eye disease, an approach taken before. However, what makes this different is that EBI‐005 has been designed specifically for delivery to the surface of the eye.

Named after a reference in the cult film "Spinal Tap," Eleven is a company to watch--Eleven was named a Fierce 15 company in 2010, and one of the Top 15 Biotech Venture Investments in H1 2012. In 2011, Celniker was named one of FierceBiotech's 2011 Women in Biotech.

- read the press release (pdf)
- see the abstract

Special Reports: FierceBiotech's 2010 Fierce 15 | The Top 15 Biotech Venture Investments in H1 2012 | FierceBiotech's 2011 Women in Biotech