Omeros Announces Positive Clinical Results of OMS201 in Patients Undergoing Ureteroscopy
SEATTLE, Dec. 29, 2010 /PRNewswire-FirstCall/ -- 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™ 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