Narsoplimab is under clinical development by Omeros and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Narsoplimab’s likelihood of approval (LoA) and phase transition for Atypical Hemolytic Uremic Syndrome (Nondiarrhea – Associated Hemolytic Uremic Syndrome) took place on 16 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 16 Dec 2022 decreased Narsoplimab’s LoA and PTSR for IgA Nephropathy (Berger’s Disease).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Narsoplimab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Narsoplimab overview

OMS-721 is under development for the treatment of thrombotic microangiopathies (TMAs) including atypical hemolytic uremic syndrome (aHUS) and thrombotic thrombocytopenic purpura (TTP), thrombotic microangiopathy, steroid-dependent Immunoglobulin A- IgA nephropathy (Berger's disease), lupus nephritis, C3 glomerulopathy and membranous nephropathy including dense deposit disease. OMS-721 can be administered by subcutaneous and intravenous routes as a solution. The drug candidate is a human monoclonal antibody which targets MASP-2. It was also under development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), wet macular degeneration, ischemia-reperfusion injury, myocardial infarction, ischemic stroke and diabetic neuropathy.

OMS-721 is also under development for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome causing coronavirus 2 (SARS-CoV-2).

Omeros overview

Omeros is a biopharmaceutical company that discovers, develops and commercializes small-molecule and protein therapeutics for large-market and orphan indications. The company’s marketed product, Omidria is a phenylephrine and ketorolac injection for use during cataract surgery or replacement of intraocular lens (IOL). The company is investigating its product candidates for use in arthroscopic, ophthalmological, and other surgical procedures including thrombotic microangiopathies, mediated glomerulopathies, addictive and compulsive disorders among others. It is also evaluating preclinical product candidates for treatment of alternative pathway disorders, central nervous system disorders, metabolic, oncologic, musculoskeletal and other disorders. Omeros is headquartered in Seattle, Washington, the US.

Quick View Narsoplimab LOA Data

Report Segments
  • Innovator
Drug Name
  • Narsoplimab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Ophthalmology
Key Developers
  • Sponsor Company: Omeros
  • Originator: University of Leicester
Highest Development Stage
  • Filing rejected/Withdrawn

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.