Omeros and Quantum Leap Announce First Patients Dosed with Narsoplimab in the I-SPY COVID-19 Trial
-- Adaptive Platform Trial is Evaluating Drugs and Investigational Products in the Treatment of Critically Ill COVID-19 Patients --
“We’re excited that narsoplimab is one of the agents that has entered the I-SPY COVID-19 Trial,” said
Narsoplimab is Omeros’ lead antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. It is the only complement inhibitor invited to participate in the I-SPY COVID-19 Trial. Narsoplimab has been administered under compassionate use to treat severely ill COVID-19 patients requiring mechanical ventilation, with impressive outcomes.
“Omeros is pleased to be working with Quantum Leap Healthcare Collaborative in this important effort,” said
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, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. 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. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new 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 small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.
Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. 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. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.
A biologics license application (BLA) is under priority review by the
About the I-SPY TRIALS
The I-SPY 2 TRIAL for stage II and III breast cancer is the longest running and most successful adaptive platform trial in oncology. Quantum Leap was able to use the existing I-SPY 2 TRIAL infrastructure methodology to develop the I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning). The I-SPY COVID Trial is designed to rapidly screen promising experimental treatments, and re-purpose existing agents to identify the most effective treatments for severely ill COVID-19 patients. The trial is a unique collaborative effort by a consortium that includes the
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at
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,” “can,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “prospects,” “scheduled,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros’ investigational product, 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory oversight, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, 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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