Aurinia Pharmaceuticals has announced the commencement of an open-label exploratory trial to assess antiviral activity of voclosporin in kidney transplant recipients (KTRs) with Covid-19.
Aurinia has also secured funding for the VOCOVID study, which is a single-centre and investigator-initiated trial being carried out by Drs Aiko P.J. de Vries and Y.K. Onno Teng at the Leiden University Medical Center (LUMC) in the Netherlands. The trial will compare voclosporin against tacrolimus.
Voclosporin, a novel calcineurin inhibitor (CNI), was developed for the treatment of patients with lupus nephritis.
Voclosporin restricts IL-2 expression by inhibiting calcineurin, as well as minimises T-cell mediated immune responses and synergistically stabilises podocytes in the kidney.
The 56-day open-label investigator-initiated trial will assess the antiviral effects of voclosporin compared to tacrolimus in stable KTRs who contracted SARS-CoV-2.
Aurinia will randomise 20 KTRs testing positive for SARS-CoV-2 and currently on dual immunosuppressives of prednisone and tacrolimus in 1:1 ratio at study entry to remain on tacrolimus or be switched to voclosporin.
According to the company, the trial’s primary endpoint is the reduction in SARS-CoV-2 viral load over 56 days, as measured by reverse transcription polymerase chain reaction (qRT-PCR).
The trial will also evaluate predefined endpoints as surrogate markers of improved viral clearance, including time to three-log reduction in viral load concentration and time to clinical recovery.
The company will monitor voclosporin treated patients for up to one year following the 56-day treatment period.
Voclosporin is not yet approved by the US Food and Drug Administration (FDA) for any indication.
Aurinia research executive vice president Dr Robert Huizinga said: “At Aurinia, we are dedicated to addressing the needs of people affected by serious diseases through scientifically rigorous and responsible drug development.
“Working with our long-time collaborators at LUMC, we established the preclinical antiviral activity of voclosporin against the SARS-CoV-2 virus with results that further highlight voclosporin’s differentiation from legacy CNIs.”
Earlier this month, ImmunityBio secured authorisation from the FDA to commence a phase I clinical study of its novel Covid-19 vaccine candidate, called hAd5-Covid-19.