omeros corp (OMER) Key Developments
Omeros Corporation Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial
Aug 18 15
Omeros Corporation announced additional positive data in the company's Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) 'aggregations of platelets' in the microcirculation of the body's organs, most commonly the kidney and brain. OMS721 is Omeros' lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of TMAs, including atypical hemolytic uremic syndrome (aHUS). The Phase 2 trial is designed to enroll primarily aHUS patients but can also enroll patients with thrombotic thrombocytopenic purpura (TTP) and hematopoietic stem cell transplant (HSCT)-related TMA. The trial has fully enrolled the first and second cohorts and is currently completing the third and final planned cohort of its dose-ranging stage. In each three-patient cohort, OMS721 is dosed for four weeks. Three patients were treated in the second or mid-dose cohort, two of whom have aHUS and one with TTP. Both patients with aHUS were on renal dialysis prior to and at the time of study enrollment. Based on the positive data from the mid-dose cohort, the high-dose cohort was initiated and an aHUS patient has already completed the study treatment period. No patient with HSCT-related TMA has yet completed dosing with OMS721. The data referenced for all patients include measures to one week following the last dose. TMAs are characterized by thrombi or clumps of aggregated platelets in small blood vessels, which lead to thrombocytopenia (below-normal platelet counts) and schistocytes (fragmentation in red blood cells) that can cause dangerously low oxygen levels in organs like the brain and kidney as well as anemia. Thrombotic microangiopathies are life-threatening and can occur both in children and adults. While thrombi, thrombocytopenia and schistocytes are hallmarks of TMAs, other markers of damage within the blood vessels include an elevated plasma lactate dehydrogenase (LDH) and undetectable or reduced plasma haptoglobin levels. In addition, an elevated creatinine level 'a result of the kidney damage caused by thrombi' is an indicator of impaired kidney function in patients who are not on renal dialysis. In the mid-dose cohort, the two patients with plasma therapy-resistant aHUS demonstrated: 47% increase in mean platelet count, resulting in both patients having counts in the normal range; 86% decrease in mean schistocyte count, with schistocytes disappearing in one patient; 71% increase in mean haptoglobin with both patients reaching the normal range during treatment, one slipping slightly below normal at one week following the last dose; and 5% decrease in the mean levels of LDH, with levels in both patients remaining slightly elevated above normal range. The mid-dose-cohort patient with TTP required repeated plasma infusion therapy prior to entering the study. Laboratory parameters did not show consistent improvement, but the patient did not require plasma therapy during treatment with OMS721 and, to date, has not required it since completing treatment. The first patient in the high-dose cohort 'a plasma therapy-resistant aHUS patient with additional complicating disorders including hepatitis C, cryoglobulinemia and lymphoma' has also completed treatment with OMS721. Prior to OMS721 treatment, the patient required repeated dialysis. Throughout treatment and following completion of the OMS721 course, the patient to date has remained off dialysis. Hematological and renal parameters showed: 63% improvement in platelet count, returning to normal levels; 100% decrease in schistocytes; Haptoglobin increased from an undetectable level and normalized; 43% decrease in LDH, resulting in a level just slightly above normal; and 24% reduction in creatinine level. As expected, patients with aHUS in the mid- and high-dose cohorts demonstrated more consistent and robust improvement in efficacy measures than patients in the low-dose cohort. As in the low-dose cohort, the drug was well tolerated by all patients in the mid- and high-dose cohorts throughout the treatment period. There have been no confirmed clinically meaningful drug-related adverse events in any clinical trials with OMS721. To date, two clinically meaningful adverse events were considered possibly related to OMS721 when first observed because an infectious etiology could not be ruled out at diagnosis, but all cultures subsequently proved negative. Specifically, one patient in the low-dose cohort was reported as possibly having an infection; however, all cultures were negative and no infection was identified. Another patient had significant diarrhea, but all tests for gastrointestinal pathogens were negative and the patient was receiving immunosuppressive therapy, including a drug very commonly associated with diarrhea. In addition, animal chronic toxicity studies have been completed and no notable adverse findings were observed. The FDA has cleared OMS721 for chronic dosing in clinical trials. Physician-requested compassionate use is ongoing, and all patients in the compassionate-use program are reported by their physicians to be doing well.
Omeros Corporation Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 10 15
Omeros Corporation announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter ended, the company reported total Revenues were $3,187,000 compared to $45,000 a year ago. Loss from operations was $15,967,000 compared to $17,217,000 a year ago. Net loss was $16,680,000 or $0.44 basic and diluted per share compared to $17,991,000 or $0.53 basic and diluted per share a year ago.
For the six months, the company reported total Revenues were $3,575,000 compared to $145,000 a year ago. Loss from operations was $33,897,000 compared to $32,901,000 a year ago. Net loss was $35,349,000 or $0.95 basic and diluted per share compared to $34,633,000 or $1.07 basic and diluted per share a year ago.
European Commission Granted Marketing Authorization for Omeros Corporation's Omidria Throughout the European Union and Additional Countries
Aug 3 15
Omeros Corporation announced that the European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1% /0.3% in the European Union (EU) for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. This approval allows for the marketing of Omidria in all EU member states plus Iceland, Lichtenstein, and Norway. Cataract surgery and lens replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015. Approval in the EU is based on the same clinical data that were the basis for the U.S. approval received from the U.S. Food and Drug Administration last year and follows the previously reported unanimous positive opinion by the European Medicines Agency'sCommittee for Medicinal Products for Human Use. Decisions about price and reimbursement for Omidria occur on a country-by-country basis. Important Risk Information for Omidria®:Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at 2% to 24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria® must be added to irrigation solution prior to intraocular use. Omidria is not approved for use in children.
Omeros Corporation to Report Q2, 2015 Results on Aug 10, 2015
Jul 31 15
Omeros Corporation announced that they will report Q2, 2015 results at 5:00 PM, Eastern Standard Time on Aug 10, 2015
Omeros Corporation, Q2 2015 Earnings Call, Aug 10, 2015
Jul 31 15
Omeros Corporation, Q2 2015 Earnings Call, Aug 10, 2015