Alexion drug fails in kidney transplant trial
Alexion’s troubles are continuing after its flagship drug Soliris flopped in a late stage trial for treatment of complications after kidney transplants.
The trial failure has come at a bad time for the rare disease specialist company, which is in the midst of a crisis after a whistleblower said the company had used fraudulent practices to boost Soliris’ sales.
The phase 2/3 PROTECT study was assessing Soliris for prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney, Alexion said in a statement.
But primary endpoint of incidence of DGF with a two-dose regimen of Soliris (eculizumab) compared with placebo did not reach statistical significance.
DGF is an early and serious complication of organ transplantation in which the transplanted organ fails to function normally immediately following transplantation, and was defined in the study as the requirement for dialysis for any reason in the first seven days post-transplant.
The primary endpoint also included incidence of death, graft loss, and loss to follow-up, including discontinuation.
In the 286-patient randomised controlled trial, incidence of death, graft loss, or loss to follow-up seven days after transplant was 35.9% in a Soliris arm, compared with 41.7% in the placebo arm.
This produced a “p” value way above the threshold for statistical significance. There was a higher rate of adverse events in the Soliris group (54.1%), compared with 44.4% in the placebo arm.
There were four deaths in the placebo group against one in the Soliris group in the same time frame. Alexion expects that data from the study will be published at a later date.
Already approved in the US for the rare diseases Atypical Haemolytic Uaemic Syndrome, and Paroxysmal Nocturnal Haemoglobinuria, Soliris is a blockbuster with sales predicted to exceed $3 billion this year.
Results of an internal investigation are pending – but former CEO David Hallal resigned earlier this month for “personal reasons” and CFO Vikas Sinha quit to “pursue other opportunities”.
Former AstraZeneca chief executive David Brennan has been parachuted in to take over from Hallal on an interim basis, while former Honeywell CFO David Anderson has replaced Sinha.
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