|Omeros Corporation Announces Additional Positive Data for OMS721 in IgA Nephropathy|
-- Magnitude of Proteinuria Reduction Consistent With Previous Cohort --
“We now have results of treatment with OMS721 in IgA nephropathy
patients both with and without concomitant steroid therapy,” stated
The current cohort study was designed to evaluate the safety and tolerability of once-weekly intravenous (IV) dosing of OMS721 and to describe the effect of the drug on 24-hour proteinuria in patients with IgA nephropathy. Twelve patients were enrolled. Per protocol, patients are required (i) to not receive corticosteroids during the study duration or for at least three months prior to screening and (ii) to be stable on an optimized dose of ACE inhibitors/ARBs (i.e., renin-angiotensin system [RAS] blockade) before enrollment. In a double-blind design, study patients were randomized 1:1 to receive either OMS721 or placebo for 12 weeks, and then both groups could receive extended OMS721 dosing at investigator discretion. Three patients were excluded from the analysis: two for unstable RAS blockade with at least a 50 percent change in dosing of RAS-blockade medication during the study, and one for untreated gastrointestinal disease that persisted throughout a substantial majority of the study duration. These conditions are known to affect proteinuria levels markedly, and results from these patients were determined by IgA nephropathy expert review to be unevaluable.
For the nine evaluable patients, median reductions in proteinuria following the initial 12-week course of treatment were 18.4 percent and 18.0 percent for the OMS721 and placebo groups, respectively. The one OMS721-treated patient whose proteinuria level remained elevated after the initial treatment course subsequently reached a 67.8-percent reduction from baseline following an additional course of OMS721 dosing.
After the initial 12-week treatment with OMS721 or placebo, all patients rolled into a dosing-extension period during which time a patient could receive, at investigator discretion, treatment with OMS721 if his/her respective 24-hour proteinuria level remained above 1 gram or the proteinuria response was less than a 50-percent reduction from baseline. Eight patients received OMS721 in this extension period, after either first receiving 12 weeks of OMS721 or placebo. Comparison with baseline of the proteinuria data after at least 18 weeks in the study (i.e., after the first course of OMS721 or placebo treatment and six-week follow-up) shows a median proteinuria reduction for this group of 55.7 percent. Four patients in this OMS721 dosing-extension period have reached between 9 and 12 months beyond baseline, and show reductions in proteinuria of 53.9 percent, 57.4 percent, 65.3 percent, and 67.8 percent. At most recent assessment, two of these four patients have continued to demonstrate sustained reductions in proteinuria for 2.5 and 5 months, respectively, after cessation of treatment with OMS721; the other two patients just recently completed treatment courses.
For the evaluable patients in the OMS721-treated and placebo groups, respectively, median ages at study start were 50 vs 33 years old; median time since diagnosis was 19 vs 9 years; and median baseline proteinuria was 2.9 vs 2.5 g/day. Forty-four percent of these patients had nephrotic-range proteinuria at baseline, ranging from approximately 4.5 to 12 g/day, and most patients had multiple comorbidities.
Consistent with all other studies conducted with OMS721, the drug was well tolerated and no safety concerns were seen in this cohort of patients. Across all 12 patients, no treatment-related serious adverse events were observed, and most reported adverse events were mild or moderate.
The OMS721 treatment-extension period in this cohort study remains
“We’re pleased with the strength of the data across a relatively small
cohort of predominantly high-proteinuria patients and with the magnitude
of the effect on proteinuria in the absence of steroid exposure,” stated
No treatments are approved for IgA nephropathy. With an annual incidence of approximately 1 per 100,000, it is estimated that 1 in 1,400 persons in the U.S. will develop IgA nephropathy in his or her lifetime. As many as 40 percent of them will develop end-stage renal disease.
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 is the effector enzyme of the lectin pathway, one of the principal complement activation pathways. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros’ lead human MASP-2 antibody.
Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome (aHUS), in immunoglobulin A (IgA) nephropathy and in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Also, two Phase 2 trials are ongoing. One is continuing to evaluate IgA nephropathy patients and has generated positive data in two cohorts of patients with IgA nephropathy (with and without concurrent corticosteroid therapy, respectively) and with lupus nephritis; the other is enrolling and has reported positive data in patients with HSCT-TMA and in patients with aHUS. OMS721 can be administered both intravenously and subcutaneously, and Omeros expects to commercialize each formulation of OMS721 for different therapeutic indications. In parallel, Omeros is developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, Omeros has established a compassionate-use program for OMS721, which is active in both the U.S. and Europe. The FDA has granted OMS721 breakthrough therapy designation for IgA nephropathy and for high-risk HSCT-TMA, orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies and for the treatment of IgA nephropathy, and fast track designation for the treatment of patients with aHUS.
Omeros also has identified MASP-3 as responsible for the conversion of
pro-factor D to factor D and as a critical activator of the human
complement system’s alternative pathway. The alternative pathway is
linked to a wide range of immune-related disorders. In addition to its
lectin pathway inhibitors, the company is advancing its development of
antibodies and small-molecule inhibitors against MASP-3 to block
activation of the alternative. pathway.
Omeros is a commercial-stage biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, complement-mediated diseases and disorders of the central
nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed
for use during cataract surgery or intraocular lens (IOL) replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. In the
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