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Omeros Announces Preliminary Results from Additional Critically Ill COVID-19 Patients Treated with Narsoplimab

SEATTLE–()–Omeros Corporation (Nasdaq: OMER), 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, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the second cohort of critically ill COVID-19 patients treated with narsoplimab in Bergamo, Italy. These patients were part of the “second surge” of COVID-19 in Italy. Narsoplimab is the company’s lead inhibitor of mannan-binding lectin-associated serine protease 2 (MASP-2), the effector enzyme of the lectin pathway of complement.

“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 Alessandro Rambaldi, MD, Professor, Department of Oncology and Hematology-Oncology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy. “All of the patients had significant ARDS with 90 percent of them intubated at the start of narsoplimab treatment, the majority had multiple comorbidities and risk factors for poor outcome, and all had failed other therapies. The results in these patients are outstanding and further support what we have learned about the pathophysiology of COVID-19, the central role of endothelial damage in the disease, and the mechanism of action of narsoplimab.”

The patients were treated under compassionate use at ASST Papa Giovanni XXIII Hospital between October 2020 and April 2021. Highlights of the study are as follows:

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 Berlin criteria) at time of intubation or ICU admission: 80% severe, 20% moderate
  • All had failed other therapies (steroids)

Narsoplimab treatment:

  • 90% were intubated at initiation of narsoplimab treatment
  • Narsoplimab was administered intravenously twice weekly; median doses administered: 6 (range 3 to 8 doses)

Results:

  • 80% recovered, survived and were discharged
  • 2 deaths

    • 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 Dr. Rambaldi and his colleagues for their continuing work with narsoplimab and their dedication to treating critically ill COVID-19 patients,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “A greater focus in the war against COVID-19 is now being placed globally on therapeutics, and we believe that narsoplimab can contribute meaningfully to that effort. Unlike other drugs for COVID-19, narsoplimab targets the inflammatory endothelial disease – a central driver across variants. Our discussions continue with government agencies and NGOs in the US and internationally, and we look forward to additional clinical trial data on narsoplimab in critically ill COVID-19 patients.”

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 the United States government through the Biomedical Advanced Research and Development Authority (BARDA). Narsoplimab is the only complement inhibitor in the I-SPY trial.

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.

About Omeros Corporation

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.

Forward-Looking Statements

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 Securities and Exchange Commission (SEC) on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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