Omeros missed the main goal of a late-stage study of one of its lead product candidates in patients undergoing arthroscopic surgeries to remove damaged knee cartilage. The Seattle biotech ($OMER) broke the news late Thursday afternoon and its shares were off 5.31% to $5.53 at 9:40 a.m. ET Friday.
Its study failed on the primary endpoint of a patient-reported symptoms score that includes knee swelling, clicking and stiffness, according to the company. Yet the developer succeeded in gaining statistically significant reductions in pain in the 344-patient study.
Despite the mixed results, the company plans to forge ahead with a second Phase III study of the treatment, known as OMS103HP, for the same use in patients having surgeries to remove damaged portions of the meniscus cartilage in the knee. That study is due to begin in the first half of 2013. As Cowen analyst Simos Simeonidis stated in an investor note this morning, the company aims to make post-operative pain the main endpoint of the next Phase III.
Development of OMS103HP has survived multiple late-stage setbacks. In March 2011, for instance, Omeros reported disappointing results after a Phase III study missed a slate of goals for use of the therapy in patients undergoing ACL surgeries.
Omeros has produced more Phase III wins with its lead drug OMS302, for which it plans to file for FDA approval in the first quarter of 2013 for use during eye surgeries. The 18-year-old biotech would like an approval to leap into the commercial realm.
- here's the release
- see the update from The Seattle Times