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Lupus trial hailed as a success despite patient deaths

Phase IIb trial of Aurinia Pharmaceuticals’ voclosporin met its objective

Aurinia PharmaceuticalsA medical charity representing patients with lupus erythematosus has welcomed the results of a study showing the efficacy of a new drug, despite the deaths of some participants.

The phase IIb trial of Aurinia Pharmaceuticals' voclosporin met its objective of improving complete remission rates in patients with lupus-related kidney disease (nephritis), becoming the first therapeutic agent to do so in a large-scale clinical trial.

The Lupus Foundation of America (LFA) said the results were “welcome and exciting news for people with lupus and their doctors who are eager to have more tolerable and effective treatment options”.

Lupus is an autoimmune disease that is hard to characterise, causing a range of symptoms that can affect a number of different organ systems, and as a result is a challenge to diagnose and treat. In around 60% of patients the disease affects the kidneys and can be particularly severe and potentially life-threatening.

Voclosporin or placebo were given to patients on top of therapy with Roche's transplant rejection drug CellCept (mycophenolate mofetil) in the study, the current standard of care for lupus nephritis, with patients on Aurinia's drug twice as likely to go into remission than those on the control therapy. 

Some of the shine was taken off the result however as there were 13 patient deaths in the study – 12 in the voclosporin group and one on placebo - which spooked investors and saw the company's share price plummet after the announcement.

Questions were also raised about the doses of voclosporin used in the 256-patient trials, and specifically why a lower dose of Aurinia's candidate seemed to perform better than a higher dose. 

The Canadian pharma company stressed that the patients in the trial were very sick, and that the adverse events reported in the study were consistent with the symptoms caused by highly-active lupus nephritis. It also said most of the patient deaths occurred among people recruited in Asia, which could be explained by different treatment standards.

Aurinia was backed by the LFA, which said the study was the first trial of a potential treatment for active lupus nephritis to reach its primary endpoint.

“We look forward to the timely commencement of a phase III trial and - should the findings confirm this study - the addition of this regimen to the arsenal of treatments available to people who have waited far too long for medicines that improve the quality of their lives,” said LFA chief executive Sandra Raymond.

The company could also draw some comfort from analysts at Leerink, who suggested that given the extremely sick patient population the FDA was likely to “view the risk/benefit of voclosporin favourably”.

If that is the case the opportunity for Aurinia could be large. At the moment the lupus market is estimated at around $1.2bn and is expected to swell to $4bn by 2020, according to figures from LifeSci Capital.

Article by
Phil Taylor

16th August 2016

From: Research, Regulatory

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