Aurinia Announces European Investigator-Initiated Trial to Evaluate Antiviral Activity of Voclosporin in Kidney Transplant Recipients with COVID-19

Aurinia Pharmaceuticals announced the funding and initiation of an open-label exploratory trial evaluating the antiviral effects of voclosporin in kidney transplant recipients (KTRs) with COVID-19 (SARS-CoV-2) – the VOCOVID study. The single-center, investigator-initiated trial (IIT) is being conducted by Drs. Aiko P.J. de Vries and Y.K. Onno Teng at the Leiden University Medical Center (LUMC) in the Netherlands and will compare voclosporin against tacrolimus.

Aiko P.J. de Vries, M.D. Ph.D., Department of Nephrology at LUMC Said: “The COVID-19 pandemic has introduced new challenges for transplant recipients who require chronic immunosuppression to maintain their transplanted organ, which puts them at high risk for a more severe course after contracting COVID-19.”

Onno Teng, MD, PhD, Department of Nephrology at the LUMC, commented, “we know from the previous PROMISE study that voclosporin can be dosed more predictably than legacy calcineurin inhibitors while maintaining the same degree of efficacy to prevent organ rejection. Preclinical data, which are being readied for peer-reviewed publication, from our institute in Leiden have demonstrated voclosporin’s superior potency in vitro against SARS-CoV-2 compared to tacrolimus.”

Organ transplant recipients who contract COVID-19 are at greater risk for complications due to the requirement of daily immunosuppressive medications to prevent organ rejection. Calcineurin inhibitors (CNIs), like voclosporin, have been shown in prior in vitro studies to inhibit viral replication. The team at the LUMC demonstrated that voclosporin inhibited viral replication of SARS-CoV-2 at an 8-fold lower concentration than tacrolimus in vitro, while maintaining cell viability of infected cells. In contrast to voclosporin, tacrolimus did not show antiviral activity against SARS-CoV-2 in vitro at clinically relevant concentrations. Therefore, given its potency and dosing advantages, voclosporin is a potentially attractive CNI for COVID-19 infected transplant patients who are already using legacy CNIs as part of their chronic immunosuppressive therapy.

Robert Huizinga, Ph.D., R.N., CNeph(C), Executive Vice President, Research at Aurinia Said: “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, As we continue to prepare for potential FDA approval and commercial launch of voclosporin for the treatment of LN, we are pleased to test the potential of voclosporin to meet the urgent needs of this specific patient population driven by the COVID-19 pandemic.”

About the VOCOVID Study

This 56-day open-label investigator initiated trial (IIT) is designed to evaluate the antiviral effects of voclosporin compared to tacrolimus in stable kidney transplant recipients (KTRs) who contracted SARS-CoV-2. At study entry, 20 KTRs testing positive for SARS-CoV-2 and currently on dual immunosuppressives of prednisone and tacrolimus will be randomized 1:1 to remain on tacrolimus or be switched to voclosporin. The 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 study will also assess predefined endpoints as surrogate markers of improved viral clearance including time to 3-log reduction in viral load concentration, time to clinical recovery – defined as free of symptoms for five days or more, and safety and tolerability. Following the 56-day treatment period, there will be an extended safety follow-up of voclosporin treated patients for up to one year.

About Voclosporin

Voclosporin is a novel calcineurin inhibitor (CNI) developed to treat patients with lupus nephritis. By inhibiting calcineurin, voclosporin blocks IL-2 expression and reduces T-cell mediated immune responses while it synergistically stabilizes podocytes in the kidney. This novel CNI has a favorable metabolic profile and a consistent, predictable dose response potentially eliminating the need for therapeutic drug monitoring.

There are currently no therapies approved by the Food and Drug Administration (FDA) to treat lupus nephritis. Additionally, current SOC yields very low complete response rates. To help address the significant unmet medical need of lupus nephritis, the FDA designated voclosporin fast track status and priority review.

Voclosporin is currently not approved by the US FDA for any indication.

About Leiden University Medical Center

As a centre of medical innovation, Leiden University Medical Centre (LUMC) strives for a (inter)nationally recognised leading role in improving the quality of healthcare. The core tasks of the LUMC are research, education, patient care, training and continuing education. The LUMC is part of the Dutch Federation of University Medical Centres (NFU). The NFU is an alliance of the eight university medical centres (UMCs) in the Netherlands.

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