27.1.2022 23:08:58 CET | ViroGates | Company Announcement

COMPANY ANNOUNCEMENT - No. 01-2022 - 27 January 2022

BIRKERØD, DENMARK - ViroGates A/S, a medical technology company developing blood tests for better triaging in hospitals to improve patient care and reduce healthcare costs, today announces that Hospital Universitario y Politécnico de La Fe (La Fe) has started using suPARnostic® in clinical routine to guide anakinra treatment in adult COVID-19 patients. 

La Fe is a reference hospital with an uptake population of approximately 300,000 people and 1,000 beds located in Valencia, Spain. La Fe is the first hospital in Spain that has implemented the use of suPARnostic® guided anakinra treatment. In addition, it is the first hospital in Spain to implement suPARnostic® TurbiLatex in routine use on the Abbott Alinity clinical chemistry analyzer in its central laboratory.

The European Medicines Agency officially approved using suPAR-guided anakinra treatment in adult COVID-19 patients in December 2021 based on the SAVE-MORE study published in Nature Medicine.

Doctor Laíz, head of the laboratory at La Fe, says: "We have high expectations for suPAR because we hope that suPAR will help us in the fight against Covid. We are very proud to be the first hospital in Spain to have suPAR in an Alinity."

Jakob Knudsen, CEO of ViroGates, says: ”We are proud to be a player in the continued battle against COVID-19. We are committed to assisting in identifying COVID-19 patients with challenged immune systems who can benefit from an early anakinra intervention. We are also happy to see that the SAVE-MORE study increasingly is translated into clinical practice to the benefit of patients.”

The announcement can be found at https://www.virogates.com/investor/announcements

For further information, please contact:

ViroGates A/S:

CEO, Jakob Knudsen

Tel. (+45) 2226 1355, email: jk@virogates.com

Certified Advisor:

Västra Hamnen Corporate Finance

Per Lönn

Tel. (+46) 40 200 250, email: per.lonn@vhcorp.se

About ViroGates

ViroGates A/S is an international medical technology company developing and marketing blood test products under the suPARnostic® brand for better triaging in hospitals to improve patient care, reduce healthcare costs and empower clinical staff.

The company was founded in 2000. Headquartered in Denmark, ViroGates' sales force covers the Nordics, Spain, and France, while distributors serve other markets.

ViroGates' shares (VIRO) are listed on Nasdaq First North Growth Market Denmark. For more information, please visit www.virogates.com.

About suPAR and suPARnostic®

suPAR is the biomarker detected by ViroGates' suPARnostic® products and is a protein in plasma, measurable in every human being. suPAR is considered a general risk status biomarker indicating disease presence, disease severity and progression, organ damage and mortality risk across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. Strong scientific evidence from more than 800 clinical trials and studies show that the higher the level of suPAR, the worse the prognosis for the patient. 

The suPARnostic® products can be used to support healthcare professionals in making clinical decisions on hospitalization or discharge of acute care patients. The increasing demands on health systems globally and tightening healthcare budgets necessitate efficiency improvements and innovative solutions in hospitals. The use of suPAR in clinical routine in emergency departments can improve patient care and reduce healthcare costs by increasing the number of discharges by up to 34% and reducing the average hospital length-of-stay by up to 6% without affecting mortality. suPARnostic® TurbiLatex is currently available on Roche Diagnostics' cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments and the Abbott Labs Architect™ and Alinity™ instruments. ViroGates works with partners to develop solutions for other platforms.

SAVE-MORE

SAVE-MORE (NCT04680949); suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19) is a pivotal, confirmatory, phase III randomized controlled trial (RCT). The trial aimed to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days, as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS). Anakinra was administered at a dose of 100mg/day SC for up to 10 days. Of 1,060 patients screened, 606 patients were randomised across 40 sites in Greece and Italy. SAVE-MORE is an investigator-sponsored study conducted independently by Professor Giamarellos-Bourboulis, with the Hellenic Institute for the Study of Sepsis being the regulatory sponsor. Sobi has supported the study with study drug and funding.

SAVE-MORE found that suPAR-guided treatment with Kineret in addition to standard of care showed considerable efficacy, reducing the risk of disease progression and death by 64 per cent compared to standard of care alone. Overall, there was a significant improvement of the clinical status by Day 28 compared to placebo (OR: 0.36 [95% CI 0.26 to 0.50] P<0.001) and this improvement was seen by Day 14.

The suPAR-guided treatment benefit of Kineret was supported by increase in the number of patients fully recovered (50.4% and 26.5%) and significantly reduction of risk of death by 55% by day 28 compared to placebo (HR: 0.45, 95% CI 0.21–0.98, P = 0.045). No new safety signals or safety concerns were observed from the use of Kineret for treatment of COVID-19.

Disclosure regulation

Prospects about the future reflect ViroGates' current expectations for future events and results. The statements are by nature inherent in risks, uncertainties and other matters that are difficult to predict or out of control. The actual results may therefore differ from the expectations expressed.

Contacts

• Jakob Knudsen, CEO, +45 2226 1355, jk@virogates.com

Attachments

• 20220127 Company Announcement 1.pdf