Aug. 8, 2012
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. OMS103HP is a proprietary drug product added to standard irrigation solutions and delivered to the operative site throughout arthroscopy to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to improve postoperative functional outcomes.
The Phase 3 clinical program for OMS103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. The primary endpoint for both trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in Omeros' earlier successful Phase 2 meniscectomy trial.
The last patient enrolled in this Phase 3 clinical trial has undergone surgery and is now participating in the study protocol's postoperative evaluations. Omeros expects to be able to announce data from this trial during the second half of 2012 after those evaluations are complete. Assuming positive data from the current trial, Omeros plans to initiate enrollment in its second Phase 3 meniscectomy trial following discussions with European regulatory authorities.
"With this enrollment milestone achieved, we expect to announce data from three of our clinical programs during the remainder of 2012," said
Gregory A. Demopulos
, M.D., chairman and chief executive officer of Omeros. "In addition to wrapping up our Phase 3 OMS103HP trial, our other Phase 3 clinical program – OMS302 for lens replacement surgery – will complete its Phase 3 trial and, if the outcome is positive, we plan to submit both US and EU marketing applications in the first part of 2013. The Phase 1 clinical trial of our PDE10 inhibitor for cognitive disorders also remains on track for 2012 data, and we expect that one or more of our other pipeline programs will advance into the clinic next year."
Omeros' OMS103HP Program
OMS103HP is Omeros' PharmacoSurgery™ product candidate being developed for use during arthroscopic procedures, including partial meniscectomy surgery, and was designed to provide a multimodal approach to preemptively block the inflammatory cascade induced by arthroscopy. OMS103HP is a proprietary combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs), each with well-known safety and pharmacologic profiles. Each of the APIs are components of generic, FDA-approved drugs that have been marketed in
the United States
as over-the-counter or prescription drug products for over 15 years and have established and well-characterized safety profiles.
In a Phase 2 clinical trial that evaluated OMS103HP in patients undergoing partial meniscectomy surgery, OMS103HP provided clinically meaningful and significantly greater efficacy than vehicle as measured by patient-reported functional scores using the Knee Injury and Osteoarthritis Outcome Score (KOOS), passive knee flexion and visual analog scale pain scores. The patient-reported outcomes measuring symptoms, pain, activities of daily living, sport and recreational activities and quality of life associated with the operated knee showed a sustained benefit through postoperative Day 90.