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Patient Dosing Initiated for OMS721 Phase 2 Program in Renal Diseases

SEATTLE, Apr 20, 2016 (BUSINESS WIRE) -- Omeros Corporation OMER, -7.83% today announced initiation of patient dosing in its OMS721 Phase 2 program in corticosteroid-dependent renal diseases. The Phase 2 clinical trial of OMS721, the company’s lead mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor being developed for complement-related diseases, is evaluating the effects of OMS721 on kidney function in patients with corticosteroid-dependent renal diseases. This new trial expands the company’s MASP platform, which includes an OMS721 Phase 3 program in progress for the treatment of atypical hemolytic uremic syndrome (aHUS) as well as an ongoing Phase 2 program of OMS721 for the treatment of other thrombotic microangiopathies (TMAs).

This new Phase 2 clinical trial includes patients with corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis. Evidence implicates the complement system, and specifically the lectin pathway, in the pathogenesis of each of these serious diseases. Despite ongoing treatment with corticosteroids, these patients have evidence of progressive kidney disease and are at high risk for kidney failure and dialysis. Continued corticosteroid use carries significant patient risks and is associated with serious side effects. There are no FDA-approved treatments for corticosteroid-dependent patients who have persistent renal inflammation. Treatments for these diseases that improve kidney function, slow disease progression or avoid long-term corticosteroid use would meet a significant unmet medical need.

The Phase 2 clinical trial is enrolling a total of approximately 16 patients across separate cohorts for each disease. The trial is evaluating markers of kidney injury and will assess whether OMS721 allows a reduction in diseased patients’ corticosteroid requirements. Patients will receive 12 weeks of OMS721 treatment and will undergo protocol-prescribed corticosteroid tapering. Data from this trial are expected in the second half of this year or the first half of 2017. Given the seriousness of the diseases included in this Phase 2 program and the lack of available therapies, if this trial demonstrates evidence that OMS721 improves kidney function, slows disease progression or reduces corticosteroid use in these patients, Omeros intends to request breakthrough therapy designation from the FDA and to initiate a Phase 3 program that meets the requirements for accelerated approval.

“We are making excellent progress in our Phase 2 program in corticosteroid-dependent renal diseases,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “These are devastating diseases – patients are at high risk...