22.9.2023 13:59:23 CEST | ViroGates | Company Announcement

COMPANY ANNOUNCEMENT - No. 15-2023 – Inside information - 22 September 2023

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, announces positive results of a randomized controlled clinical trial on suPAR-guided antibiotic treatment in sepsis presented today, Friday the 22^nd of September 2023, at the European Shock Conference in Vienna, Austria by Dr Maria Adami from the Hellenic Sepsis Group.

Sepsis is a deadly disease and is estimated to account for around 11 million deaths annually. Early treatment is pivotal but often not initiated, as early diagnosis is missed.

Current guidelines suggest that patients admitted to the emergency department (ED) should be treated for sepsis if they have at least two of three signs of risk for sepsis (2 or 3 points in the qSOFA score system). However, if a patient has only one sign of risk, treatment is often delayed to limit the use of unnecessary antibiotics. However, some patients with only one risk sign require early treatment to prevent progression and the challenge is to find the ones that benefit from early treatment. It has previously been shown that suPAR is a strong prognostic biomarker in sepsis, and during the COVID-19 pandemic, suPAR-guided treatment with anakinra was shown to reduce progression to respiratory failure.

Today, Dr Maria Adami, on behalf of the Hellenic Sepsis Group, has reported the results of the SUPERIOR double-blinded, randomized clinical trial, recruiting patients with suspected infections visiting the ED from two hospitals in Greece, presenting with one risk sign (1 point in the qSOFA score) and a suPAR level equal to or above 12 ng/ml.

1650 patients were screened for their suPAR level in the ED using suPARnostic® and 91 patients with a qSOFA score of 1 and suPAR equal to or above 12 ng/ml were randomized to receive either one dose of meropenem, an antibiotic treatment (44 patients), or one dose of placebo (47 patients). The study met its primary endpoint: Meropenem treatment guided by suPARnostic® was accompanied by significantly lower odds for progression into sepsis compared to placebo (OR: 0·28, 95% CI 0·10 – 0·76, p = 0·012). An additional significant benefit for patients treated early with meropenem was a relative decrease in their SOFA score on day 2 and a significantly faster recovery from the infection.

The SUPERIOR study shows that the measurement of suPAR in patients with one risk sign (1 point of qSOFA score) identifies a subgroup of patients at high risk of an unfavorable outcome and early deterioration if not treated. These patients receive significant benefits from early meropenem treatment, guided by suPARnostic®.

The SUPERIOR trial is chaired by Professor Evangelos J. Giamarellos-Bourboulis from The National and Kapodistrian University of Athens and President of the Hellenic Institute for the Study of Sepsis.

Prof. Giamarellos-Bourboulis states: “Early start of antibiotics is the cornerstone of sepsis management. Results of the SUPERIOR trial outscore that when in doubt for risk of sepsis, suPAR measurements indicate the patients who need to be treated with antibiotics.”

Jesper Eugen-Olsen, Chief Scientific Officer at ViroGates, says: “We are very proud that our suPARnostic® technology can help to identify patients at risk of developing sepsis at an early stage and thereby enable these patients to benefit from immediate treatment. This is truly an important milestone in the combat against sepsis.”

Jakob Knudsen, Chief Executive Officer at ViroGates, says: “We look forward to hospitals embracing our products to improve sepsis care. Using suPARnostic® to find patients needing medical intervention is a value proposition aligned with how hospitals usually use biomarkers, and we expect to see high customer interest based on the important findings from Prof. Giamarellos-Bourboulis’ group.”

ViroGates maintains its guidance for the financial year 2023.

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 Spain, France, and Benelux, 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 900 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. The increasing demands on health systems globally and tightening healthcare budgets necessitate efficiency improvements and innovative solutions in hospitals. The use of suPAR in triage in emergency departments can identify patients in low risk of disease progression (supports discharge) and high risk patients that can benefit from early treatment to lower the risk of disease progression. suPARnostic® TurbiLatex is currently available on Roche Diagnostics’ cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments, the Abbott Labs Architect™ and Alinity™ instruments and the Beckmann Coulter AU 5800 instrument. ViroGates works with partners to develop solutions for other platforms. ViroGates has recently launched its Point of Care suPARnostic® POC+ product, a platform that uses only a few drops of finger-prick blood instead of plasma for full quantitative suPAR results in less than 20 minutes.

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

• 20230922 - ViroGates comp. ann. 15.pdf