Policy & Regulation
First Patient Dosed in Phase II Trial of Debiopharm's Antiviral Alisporivir Against Covid-19
19 January 2021 - - The first patient dosed in an investigator-initiated, randomized phase II, open-label clinical trial for Switzerland-based biopharmaceutical company Debiopharm's antiviral alisporivir (Debio 025), the company said.

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 not requiring medical ventilation nor exhibiting 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 and radiological efficacy, safety and tolerability of the compound plus Standard of Care 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.

Involved in anti-viral research for over 20 years, Debiopharm has maintained its commitment to fighting cancer and infectious diseases.

In addition to its anti-infective alisporivir, the company focuses on developing novel antibiotics to help battle highly-resistant "super-bugs" fueling the growing crisis in antibiotic resistance.

Despite the substantial financial responsibility that this COVID-19 trial represents expected to reach several millions in clinical research and product supply costs - the company has committed to donating all potential commercial revenue to fund research against infectious diseases.

If phase II results show the results required to advance to phase III, Debiopharm will seek to partner with a larger global pharmaceutical company or public healthcare organization for rapid patient access.

Debiopharm develops innovative therapies targeting high unmet medical needs in oncology and infectious diseases.