Debiopharm | Phase II research against covid-19 launched
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Antiviral Alisporivir: a valuable additional therapy to SOC
Debiopharm, a Swiss biopharmaceutical company, announced the first patient dosed in an investigator-initiated, randomised 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, hospitalised COVID-19 patients who do not require medical ventilation andhave 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.
Debiopharm, awarded the Swiss Biotech Success Story 2020, develops innovative therapies targeting high unmet medical needs in oncology and infectious diseases. Bridging the gap between disruptive discovery products and real-world patient reach, they identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialisation partners to maximise patient access globally.