What This New Trial Means for Eleven Biotherapeutics
Eleven Biotherapeutics released its most recent clinical trial results, and its drug candidate did not meet either of its two co-primary endpoints.
Biotechs are generally riskier companies. A single failed trial can make or break a company. Eleven Biotherapeutics Inc. (NASDAQ: EBIO) felt this pressure when it released its most recent clinical trial results.
The company announced its top-line results from the OASIS study. This was the first pivotal Phase 3 study of its lead drug candidate, EBI-005, in moderate to severe dry eye disease. In this study, EBI-005 did not meet either of its two co-primary endpoints.
In terms of the study, there was no statistically significant difference between the EBI-005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI-005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints.
The differences between the two groups were not statistically significant, but the company believes the differences were not clinically meaningful. EBI-005 was generally well tolerated in the Phase 3 study, with fewer than 5% of patients reporting eye irritation and no treatment related serious adverse events. Overall, 92% of patients completed the study, with 33 patients having dropped out of the EBI-005 group and 20 patients having dropped out of the vehicle control group.
Abbie Celniker, Ph.D., president and CEO of Eleven Biotherapeutics, commented on the trial:
We are disappointed that our Phase 3 study in dry eye disease did not meet its primary efficacy endpoints, but we are encouraged that we continue to see a favorable tolerability profile for EBI-005. Our key focus will be on continuing to develop EBI-005 to meet unmet medical needs in allergic conjunctivitis, based on our previously-reported Phase 2 data and scientific rationale supporting EBI-005 as a treatment for allergic conjunctivitis. Based on these top-line results, the company does not see an immediate path forward for EBI-005 in dry eye disease, and we will not be initiating the second Phase 3 study of EBI-005 in dry eye disease that we had planned to start in the second half of this year. However we need to further assess the results from the OASIS study to fully inform our evaluation of future plans in dry eye disease, including the ongoing Phase 3 safety study.
Shares of Eleven Biotherapeutics closed Friday down 4.3% at $11.97. In premarket trading Monday, shares dropped even lower, about 72% to $3.32. The stock has a consensus analyst price target of $27.67 and a 52-week trading range of $7.22 to $14.07.
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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
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