ViroGates A/S, a Danish medical technology company specializing in inflammation biomarker testing, has finalized an amendment to its agreement with Swedish Orphan Biovitrum AB (Sobi) to expand their collaboration on developing the suPARnostic® diagnostic platform for use with Sobi's anti-inflammatory drug Kineret® (anakinra).
The expanded agreement, announced on March 19, 2025, builds upon their initial collaboration established in June 2023. The partnership now encompasses not only the development of suPARnostic® TurbiLatex for commercial use in the US market but also supports Sobi's post-approval commitments with the European Medicines Agency (EMA) for compliance with the new EU In Vitro Diagnostic Regulation (IVDR) requirements.
Expanded Collaboration Scope
Under the amended agreement, both companies will continue to fund the analytical development work required for US FDA and EU IVDR regulatory submissions. ViroGates will be responsible for conducting the development work and obtaining additional clinical data to support these applications.
Jakob Knudsen, CEO of ViroGates, commented on the collaboration: "We are happy to be working with Sobi to fulfil the post-authorisation and post-approval commitments in the US and EU. The work is ongoing within our Polish laboratory partner Nutopi Sp. z o. o. Much of the laboratory-oriented work will now be initiated, and we will also reach out to academic partners to see how we can supply additional clinical data that the FDA expects to see to potentially issue a market clearance in the US."
The amendment extends certain timelines and introduces a royalty payment clause that will allow Sobi to recover its investments in the development through sales in both the US and EU markets. Additionally, Sobi has been granted an option to engage in further development efforts to apply suPARnostic® TurbiLatex to instrument platforms beyond those initially targeted.
Clinical Foundation and Regulatory Status
The collaboration is built upon promising clinical evidence from the SAVE-MORE phase 3 study, published in Nature Medicine in September 2021. This pivotal trial demonstrated that suPAR-guided anakinra treatment significantly improved outcomes and reduced progression to severe respiratory failure and mortality in patients hospitalized with COVID-19 pneumonia requiring supplemental oxygen.
In November 2022, Sobi received Emergency Use Authorization (EUA) from the FDA for Kineret® for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and likely to have elevated plasma suPAR levels.
The suPARnostic® diagnostic test is not yet commercially available in the US. To identify patients who might benefit from Kineret® treatment, an alternative patient identification method was developed based on commonly measured patient characteristics, including age, pneumonia severity, smoking status, and various clinical parameters.
The suPAR Biomarker and suPARnostic® Platform
The soluble urokinase plasminogen activator receptor (suPAR) is a protein biomarker present in plasma that serves as an indicator of inflammation and immune system activation. ViroGates' suPARnostic® products detect suPAR levels, which correlate with disease presence, severity, progression, organ damage, and mortality risk across various conditions including cardiovascular diseases, kidney diseases, type 2 diabetes, and cancer.
According to ViroGates, evidence from over 1,000 clinical trials and studies demonstrates that higher suPAR levels correlate with worse patient prognoses. The suPARnostic® platform can help healthcare professionals make informed decisions regarding hospitalization, discharge, and treatment strategies.
The suPARnostic® TurbiLatex test is currently compatible with several major diagnostic platforms, including Roche Diagnostics' cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments, Abbott Labs Architect™ and Alinity™ instruments, and the Beckmann Coulter AU 5800 instrument.
Kineret® Therapeutic Applications
Kineret® (anakinra) is an interleukin-1α and β receptor antagonist with multiple approved indications. In the US, it is indicated for rheumatoid arthritis, neonatal-onset multisystem inflammatory disease (NOMID), and Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
In the EU, Kineret® has broader approved indications, including rheumatoid arthritis, cryopyrin-associated periodic syndromes, Familial Mediterranean fever, Still's disease, and COVID-19 in adult patients with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure as determined by elevated suPAR levels (≥ 6 ng/ml).
Market Implications
This expanded collaboration represents a significant step toward precision medicine in inflammatory conditions, potentially allowing for more targeted use of Kineret® based on objective biomarker measurements. For ViroGates, successful regulatory approval would open substantial commercial opportunities in both the US and European markets.
The partnership also highlights the growing importance of companion diagnostics in optimizing therapeutic interventions, particularly for complex inflammatory conditions where patient stratification can significantly improve treatment outcomes and resource allocation.
As the companies work toward regulatory submissions in both regions, the expanded collaboration underscores the clinical utility of the suPAR biomarker in guiding treatment decisions and potentially improving patient outcomes across multiple inflammatory conditions.
