Swiss biopharmaceutical firm Debiopharm has started the dosing of the first patient in a Phase II proof-of-concept clinical trial of its antiviral alisporivir (Debio 025) for treating hospitalised Covid-19 patients.
The investigator-initiated, randomised, open-label study will be conducted by the AP-HP to evaluate the efficacy and safety of the cyclophilin inhibitor in treating early-stage Covid-19 patients not needing medical ventilation or with signs of acute respiratory distress syndrome.
The trial will have 90 hospitalised Covid-19 patients in various French centres.
Analysing the reduction in Covid-19 viral load in alisporivir-treated patients will be the trial’s primary objective.
Clinical and radiological efficacy, safety and tolerability of alisporivir, plus standard of care (SOC) versus SOC alone will be analysed as the secondary objective.
Participants in the investigational group will be given 600mg twice daily dose of alisporivir either orally or through a nasogastric tube for 14 days.
The trial is led by Greater Paris University Hospitals Biology and Pathology Department of the Henri Mondor Hospital Group head, virologist, professor Jean-Michel Pawlotsky.
Pawlotsky said: “New evidence generated by our research group suggests that alisporivir’s antiviral activity could work by decreasing the viral load in the cells and reducing the risk of pulmonary damage caused by an excessive immune response from infected patients.
“The treatment is expected to be most effective in the early stages of infection by inhibiting the virus’ capacity to replicate and multiply, potentially due to the drug’s capacity to accumulate in the lungs and strong distribution throughout the body overall.”
In preclinical in vitro research from the Mondor Institute of Biomedical Research, alisporivir had demonstrated evidence for its effectiveness against the replication of SARS-COV-2.
Debiopharm CEO Bertrand Ducrey said: “The preliminary evidence provides a scientific rationale for this Phase II trial, with hopes that treatment will help patients to avoid advancing to more life-threatening phase of the Covid-19 infection.”
In October 2019, Debiopharm started enrolling patients in its CATRIPCA Phase I clinical trial evaluating Debio 1143 in combination with Merck’s Keytruda for the treatment of cancer.