Omeros Corporation (NASDAQ: OMER) reported the publication of results from a Phase 2 trial investigating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. OMS103HP is Omeros' product candidate being developed for use during arthroscopic procedures and is designed to provide a multimodal approach to preemptively block the inflammatory cascade induced by arthroscopy.
The article reports on a prospective, multicenter, double-blind, randomized, vehicle-controlled study. Of the 161 patients who were enrolled and treated, 143 patients met the predetermined surgical and data collection criteria and were included in the data analysis (71 OMS103HP and 72 vehicle). There were no significant differences in demographic characteristics between the two treatment groups.
Pain scores in the immediate 24-hour period and up to seven days postoperatively were measured using a validated, 100-point, visual analog scale (VAS). Range of motion assessments were made at baseline and day seven postoperatively. The protocol was amended to collect patient self-reports using the Knee Injury and Osteoarthritis Outcome Score (KOOS), which consists of the following five subscale scores: symptoms, pain, activities of daily living, sport and recreation function, and knee-based quality of life. The KOOS subset consisted of 70 subjects (33 OMS103HP and 37 vehicle). OMS103HP was well tolerated, and adverse events were more frequent in the vehicle group.
Results of the trial demonstrated that OMS103HP provided clinically meaningful and significantly greater efficacy than vehicle as measured by VAS pain scores, passive knee flexion and patient-reported functional scores using the KOOS. The patient-reported outcomes scores showed a sustained benefit through postoperative Day 90 across all five KOOS subscales.
"Knee arthroscopy for meniscectomy has a variable recovery course with many patients limited by the surgical procedure rather than the actual meniscal pathology," said William E. Garrett, Jr., M.D., Ph.D., professor of orthopaedic surgery at Duke University Medical Center and lead author of the article." OMS103HP was developed to prevent much of the inflammation and pain caused by arthroscopic surgery. This study verifies the efficacy of OMS103HP using objective and subjective measures of knee function and pain. Treatment throughout surgery allowed better functional improvement at one month and even up to three months postoperatively. That should provide clear benefits to patients and surgeons."
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.
An ongoing Phase 3 clinical program is evaluating OMS103HP'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 to be conducted in North America and Europe. Omeros expects data from the North American trial in the first half of 2012. The Company is in discussions with European regulatory authorities regarding the second clinical trial and, assuming sufficient resources, plans to begin that trial during the fourth quarter of 2011. The primary endpoint for these trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure.
Source: Omeros Corporation