ViroGates A/S announced an agreement with Sobi for the development of suPARnostic® for commercial use in the US in combination with the pharmaceutical product Kineret® (anakinra). The agreement is related to the development and regulatory work associated with approaching the United States Food and Drug Administration (FDA) to make suPARnostic® available to US hospitals in connection with Kineret® ("anakinra") for the treatment of COVID-19 in hospitalised adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Under the agreement, Sobi will fund the work requested by the FDA, to be carried out by ViroGates to make suPARnostic®® commercially available in the US.

The agreement provides for a stepwise approach to the initiation of work packages. Sobi has the exclusive right to decide upon initiating work packages based on the outcome of meetings with the FDA and the achievement of previous development steps. The funding to ViroGates will be repaid to Sobi through subsequent capped royalties based on US sales.

The agreement is based on the Emergency Use Authorisation granted to Sobi in November 2022 for Kineret® as reported in ViroGates company announcement 25-2022 and the results of suPAR-guided Kineret treatment from the SAVE-MORE phase 3 study, published in Nature Medicine on 3 September 2021. COVID-19 can progress to severe respiratory failure and death due to an excessive inflammatory responsei. Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1a and b, which play a role in COVID-19-induced hyperinflammation.

Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression. suPAR-guided Kineret treatment was shown to improve outcomes and reduce progression to severe respiratory failure and mortality in patients hospitalised with COVID-19 pneumonia requiring supplemental oxygen, and the benefits were maintained long-term. This illustrates the benefit of measuring suPAR levels to stratify patients for treatment.