Omeros Announces Publication of Phase 2 Clinical Results for OMS103HP in Arthroscopy: The Journal of Arthroscopic and Related Surgery
SEATTLE, June 29, 2011 /PRNewswire via COMTEX/ --
Omeros Corporation (NASDAQ: OMER) today 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 titled "Novel Drug, OMS103HP, Reduces Pain and Improves Joint Motion and Function over 90 Days following Arthroscopic Meniscectomy" is currently available on line at www.arthroscopyjournal.org and will appear in the August 2011 print edition of Arthroscopy: The Journal of Arthroscopic and Related Surgery.
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(TM) 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.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery(TM) platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, bleeding and central nervous system disorders.
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, statements regarding the ongoing Phase 3 clinical program evaluating OMS103HP in patients undergoing partial meniscectomy surgery, including when data will be available from the North American clinical trial and when the clinical trial in Europe will begin, and Omeros' expectations regarding its ability unlock orphan GPCRS and add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2011. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
SOURCE Omeros Corporation