Omeros Announces Preliminary Results from Additional Critically Ill COVID-19 Patients Treated with Narsoplimab
-- Study Patients Comprise Second Cohort from
“The COVID-19 patients in this group were even sicker than those in the first cohort of patients treated with narsoplimab at our institution during the pandemic’s outbreak,” said
The patients were treated under compassionate use at
Baseline characteristics of the 10 study patients
- Median age: 65 years (range 41 to 79 years)
- 90% were men
- All had comorbidities/risk factors for poor outcome (i.e., diabetes, cardiovascular disease/hypertension, overweight/obese, dyslipidemia)
Acute respiratory distress syndrome (ARDS) severity (by
Berlincriteria) at time of intubation or ICU admission: 80% severe, 20% moderate
- All had failed other therapies (steroids)
- 90% were intubated at initiation of narsoplimab treatment
- Narsoplimab was administered intravenously twice weekly; median doses administered: 6 (range 3 to 8 doses)
- 80% recovered, survived and were discharged
- 76-year-old man from complications of pre-existing cardiomyopathy; received 3 doses of narsoplimab
- 68-year-old man from multi-organ failure; narsoplimab dosing was initiated after 13 days of intubation
Omeros plans to publish detailed data from the study in a peer-reviewed scientific journal.
“We are grateful to
Narsoplimab is being evaluated in the I-SPY COVID-19 Trial, an adaptive platform clinical trial enrolling critically ill COVID-19 patients. The trial is sponsored by Quantum Leap Healthcare Collaborative and is funded in part by
Narsoplimab holds Breakthrough Therapy and Orphan designations in both hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and IgA nephropathy. The Biologics License Application for narsoplimab in HSCT-TMA is under Priority Review by FDA. The drug also is in Phase 3 clinical trials for IgA nephropathy and atypical hemolytic uremic syndrome.
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company’s PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. 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. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risk that results of ongoing or future clinical trials may differ substantially from those of compassionate-use studies; risks associated with product commercialization and commercial operations, regulatory processes and oversight, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the
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