Eleven Bio's lead product candidate fails in Phase 3 study; shares plunge 78%

May 18, 2015 7:46 AM ETSesen Bio, Inc. (SESN)SESNBy: Douglas W. House, SA News Editor3 Comments
  • A Phase 3 trial, called OASIS, evaluating Eleven Biotherapeutics' (EBIO) lead product candidate, EBI-005, in patients with moderate-to-severe dry eye disease failed to achieve either of its co-primary endpoints of total corneal fluorescein staining score  and the patient-reported measurement related to ocular pain and discomfort compared to baseline at week 12.
  • There was no statistical difference between the EBI-005 cohort and the control group on the co-primary endpoints or any of the secondary endpoints. Both groups showed statistically significant improvements from baseline on the co-primaries while the change from baseline was higher in the control group than the EBI-005 group.
  • Considering the disappointing results, the company does not intend to proceed with a second Phase 3 in dry eye disease. It will continue its development of EBI-005 in allergic conjunctivitis, however.
  • The company will conduct a conference call this morning at 8:30 am ET to discuss the results.
  • EBI-005 is a recombinant protein that blocks (binds to) the interleukin-1 receptor, which plays a key role in inflammation.
  • Shares crater 78% premarket on robust volume.

This was corrected on 02/04/2019 at 3:50 PM. premarket action added

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