Omeros Announces Clinical Development Programs for OMS103HP and OMS302
SEATTLE, May 19, 2011 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it is advancing two of its product candidates from its PharmacoSurgery™ platform – OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery – into Phase 3 clinical development programs. Both of these product candidates are added to standard irrigation solutions and delivered intra-operatively to the operative site throughout the surgical procedure to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.
"I am pleased to report today that we have already begun advancing Phase 3 clinical programs for OMS103HP and OMS302," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Both of these drugs generated positive efficacy and safety data in large Phase 2 clinical trials and, based on our analysis of those data, we are optimistic that each drug's clinical benefits will be further demonstrated in its respective Phase 3 clinical program."
The OMS103HP Phase 3 clinical program will evaluate the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program will 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 used in the successful Phase 2 meniscectomy trial.
OMS302 will be evaluated for safety and efficacy in patients undergoing intra-ocular lens replacement surgery. The trials will enroll both cataract surgery and refractive lens exchange patients. This clinical program will involve two randomized, double-blind, placebo-controlled, multicenter trials. The first trial will be conducted in North America and data are expected in the first half of 2012. Omeros will initiate the second trial in Europe following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials – maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain – are the same as those achieved in the recently completed 221-patient Phase 2b trial.
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.
In the first quarter of 2011, Omeros announced that OMS103HP failed to meet pre-specified efficacy endpoints in a Phase 3 clinical program in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Omeros is unable to draw any conclusions about OMS103HP's effect in the Phase 3 ACL program due to confounding factors, and the Company has no plans to conduct additional ACL reconstruction trials at this time. The primary endpoint for Omeros' meniscectomy Phase 3 trials is different than that used in its ACL program. Accordingly, Omeros believes that the results of its ACL program do not affect the viability of its meniscectomy program.
Omeros' OMS302 Program
OMS302 is Omeros' PharmacoSurgery™ product candidate being developed for use during ophthalmological procedures including cataract and other lens replacement surgery. OMS302 is a proprietary combination of an anti-inflammatory API and an API that causes mydriasis (pupil dilation), each with well-known safety and pharmacologic profiles. FDA-approved drugs containing each of these APIs have been used in ophthalmological clinical practice for more than 15 years, and both APIs are contained in generic, FDA-approved drugs.
In a Phase 2b clinical trial that evaluated OMS302 in patients undergoing cataract surgery, OMS302 demonstrated clinically meaningful and statistically significant benefits in both prespecified co-primary endpoints – maintenance of intraoperative mydriasis and reduction of pain in the early postoperative period. OMS302 also reduced the frequency of complaints of moderate and severe pain.
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™ 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. 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 and include management's expectations regarding the data generated by the Phase 3 clinical programs of OMS103HP and OMS302, when it will be able to report data from these programs, and that 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. 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