Canadian Lupus drug to enter Phase III with Worldwide Clinical Trials

By Dani Bancroft

- Last updated on GMT

Worldwide Clinical Trials supporting Ph III trial of Lupus drug

Related tags Clinical trial Kidney

Aurinia Pharmaceuticals Inc. will use the CRO Worldwide Clinical Trials’ services for its Phase III trial for Lupus nephritis.

Lupus nephritis (LN) is damage to the kidneys estimated to occur in more than 60% of patients with the autoimmune disease Systematic Lupus erythematosus (SLE).

The inflammatory condition leads to a loss of renal function and in serious cases, end-stage renal disease (ESRD) – kidney failure.

Victoria, Canada-based Aurinia will begin AURORA, a Phase III trial for the small molecule immunosuppressant, voclosporin, using the services of the US-based contract research organization (CRO) Worldwide Clinical Trials (WCT).

Voclosporin is Aurinia’s oral calcineurin inhibitor (CNI) that the firm claims will reduce the need for chemotherapeutic agents and steroids, which are part of the current standard treatment regime for Lupus.

Aurinia explained that LN is easier to treat than SLE because the outcomes of the disease are fairly straightforward, with endpoints like the presence of proteins in urine being easily monitored.

Peter Benton, President and COO of WCT, claimed Aurinia’s Voclosporin has the potential to become the first US FDA-approved treatment for LN.


In a statement, the firm added that should voclosporin get approval, it anticipates the drug will be under patent protection for US, European, and Japanese markets until 2027 under the Hatch-Waxman Act.

This follows on from the firm's deal with API manufacturer Lonza last month​, which will supply voclosporin on an exclusive basis for up to 20 years if approval is successful.

Charles Rowland, CEO of Aurinia, said, “We are on track to commence the AURORA trial in the second quarter of 2017, and we expect the results from this study will support a New Drug Application (NDA) submission to the FDA.”


Developing therapies for SLE and its complications is a challenge for the industry​ because of the high variation of symptoms from patient to patient. 

The first treatment or Lupus in 50 years was by GSK, which was granted FDA approval for the biologic immunosuppressant Belimumab in 2011.

Since then, there has been a small revival in biotech and pharmaceutical firms looking to work on the indication. These include therapies from the French firm Neovacs​ and UK-based ImmuPharma, which also has a Phase III candidate Lupuzor in trials for SLE partnered with the CRO Simbed-Orion​.

However, belilmumab was found not effective at treating SLE complications such as LN, which other biotechs like TxCell​ are addressing.

Image: iStock/Ben-Schonewille

Related news

Show more

Related products

show more

Ultra Low Temperature Packaging solutions

Ultra Low Temperature Packaging solutions

Content provided by Almac Group | 12-Feb-2024 | Case Study

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable...

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Related suppliers

Follow us


View more