28 October 2020 - - Canada-based clinical biopharmaceutical company Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (TSX: AUP), focused on advancing voclosporin across multiple indications, has closed a funding and initiated an open-label exploratory trial evaluating the antiviral effects of voclosporin in kidney transplant recipients with COVID-19 (SARS-CoV-2) the VOCOVID study, the company said.

The single-center, investigator-initiated trial is being conducted by Drs. Aiko P.J. de Vries and Y.K. Onno Teng at the Leiden University Medical Center in the Netherlands and will compare voclosporin against 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, 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.

This 56-day open-label investigator initiated trial is designed to evaluate the antiviral effects of voclosporin compared to tacrolimus in stable kidney transplant recipients 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.

Voclosporin is a novel calcineurin inhibitor 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 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.

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. The NFU is an alliance of the eight university medical centres in the Netherlands.

Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.

The company is currently seeking FDA approval of the investigational drug, voclosporin, for the potential treatment of lupus nephritis and evaluating voclosporin ophthalmic solution in a Phase 2/3 study for the treatment of dry eye syndrome.

The company's head office is in Victoria, British Columbia and its US commercial hub in Rockville, Maryland, focuses its development efforts globally.