Phase II Research Against COVID-19 Launched In France With Debiopharm's Antiviral Alisporivir

- Pre-clinical in vitro research from the Mondor Institute of Biomedical Research (INSERM U955) has shown evidence for the effectiveness of alisporivir against the replication of SARS-COV-2 (COVID-19)¹

- A randomized, investigator-initiated, phase II study, conducted by the AP-HP (Greater Paris University Hospitals), has been launched to assess the efficacy and safety of the compound in 90 hospitalized COVID-19 patients from multiple centers in France

- Debiopharm has opted to forgo any financial benefit from treatment and pledges to donate all proceeds to a non-profit foundation dedicated to infectious disease research

LAUSANNE, Switzerland, Jan. 18, 2021 /PRNewswire/ -- Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company, announced today the first patient dosed in an investigator-initiated, randomized phase II, open-label clinical trial for its antiviral alisporivir (Debio 025). The study will be conducted by the AP-HP to assess the efficacy and safety of the cyclophilin inhibitor in the treatment of early stage, hospitalized COVID-19 patients who do not require medical ventilation and have not exhibited signs of acute respiratory distress syndrome. The primary objective of this 'proof-of-concept' trial is to evaluate the reduction in COVID-19 viral load in alisporivir treated patients. The secondary objective involves the analysis of clinical & radiological efficacy, safety and tolerability of the compound plus Standard of Care (SOC) compared to SOC alone. Patients in the investigational arm will receive alisporivir either orally or via a nasogastric tube, at the dose of 600mg twice daily for 14 days during the trial led by Prof. Jean-Michel Pawlotsky, virologist, Head of the Biology and Pathology Department of the Henri Mondor Hospital Group, Greater Paris University Hospitals. The trial, supported by both the hospital group and Debiopharm, will be carried out in multiple centers in France including the Henri Mondor Hospital Group.

Medical observations have shown that viral infections such as COVID-19 can be life-threatening due to an overreaction of the body's immune defense system. Part of the cyclophilin inhibitor class of antivirals, this macrocyclic cyclophilin inhibitor could prove to be a valuable additional therapy to SOC due to its non-immunosuppressive nature.