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.