Benzinga | Oct 27, 2020 04:14PM EDT

Aurinia Announces European Investigator-Initiated Trial To Evaluate Antiviral Activity Of Voclosporin In Kidney Transplant Recipients With COVID-19

VICTORIA, British Columbia--(BUSINESS WIRE)--

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today 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.

"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," said Aiko P.J. de Vries, M.D. Ph.D., Department of Nephrology at LUMC.

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.

"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," stated Robert Huizinga, Ph.D., R.N., CNeph(C), Executive Vice President, Research at Aurinia. "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."