Omeros Announces Positive Clinical Results of OMS201 in Patients Undergoing Ureteroscopy
SEATTLE, Dec. 29, 2010 /PRNewswire via COMTEX/ --
Omeros Corporation (Nasdaq: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery(TM) product candidate. OMS201 is a proprietary combination of an anti-inflammatory agent and a smooth muscle relaxant, each with well-known safety and pharmacologic profiles.
Based on the successfully completed Phase 1 trial of a lower concentration of OMS201, this Phase 1/2 study was designed to evaluate the safety and systemic absorption of two sequentially higher concentrations of OMS201 added to standard irrigation solution and delivered to patients undergoing ureteroscopy for removal of ureteral or renal stones. This multicenter, double-blind, placebo-controlled study also explored potential efficacy endpoints but was not powered to assess efficacy. Based on an interim analysis of the pharmacokinetic data, which demonstrated low maximal systemic absorption of the active ingredients, trial enrollment was truncated from the originally planned 36 patients to a total of 24 patients.
OMS201 was safe and well tolerated in this study. The incidence of adverse events was similar in the two OMS201-concentration arms and the group receiving vehicle. No adverse events were considered treatment-related by investigators. There were no deaths or discontinuations for adverse events. Only one serious adverse event was reported, which occurred in a vehicle-treated patient.
"We are pleased with the results of this trial, which demonstrated an absence of side-effects even at a concentration of OMS201 ten times higher than that examined in our earlier Phase 1 clinical study," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These data will help us to design subsequent trials evaluating the efficacy and safety of OMS201 in patients undergoing urologic procedures."
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation 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 five ongoing clinical development programs, including four from its PharmacoSurgery(TM) platform, the most advanced of which is in a Phase 3 clinical program, and one from its Addiction program. Omeros may also have the near-term capability, through its GPCR program, to add wholly new drug targets to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of antibody and small-molecule preclinical programs targeting inflammation 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 the Company's ability to design subsequent trials evaluating the efficacy and safety of OMS201 in patients undergoing urologic procedures. 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 November 4, 2010. 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