AstraZeneca has opted to terminate a late-stage trial evaluating Ultomiris (ravulizumab) in treating a common complication of kidney transplantation, dashing the company’s hopes of expanding the drug’s use case into a new indication.
In a pipeline update released alongisde its Q3 earnings, the pharma company announced it would no longer forge ahead with the Phase III AWAKE trial (NCT06830798), which was evaluating Ultomiris’ ability to reduce the severity of delayed graft function in high-risk adult patients post-kidney transplant. The study primarily focused on Ultomiris’ potential to increase the time a patient remained dialysis free after transplant over placebo.
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Currently, researchers estimate that around 20-50% of patients experience delayed graft function when receiving a kidney from a deceased donor, while this value drops to between 4% and 10% when a recipient’s kidney is taken from a living donor. These patients almost always require dialysis, which can be highly burdensome and impactful on quality of life.
AstraZeneca made this call based on analysis from the trial’s independent data monitoring committee, which noted that Ultomiris was unlikely to meet the trial’s primary endpoint.
Though the C5 inhibitor was deemed unlikely to meet the efficacy bar in AWAKE, researchers did find it to be safe and tolerable within this patient population, and no new safety signals were observed.
Ultomiris’ rare disease empire
Despite AWAKE’s termination , AstraZeneca has still managed to notch up five rare disease indications for Ultomiris in the US.
Most recently in October, the US Food and Drug Administration (FDA) gave Ultomiris the accelerated regulatory greenlight as a proteinuria-reducing therapy for adults with immunoglobulin A nephropathy (IgAN). The therapy could soon see further expansion into another indication as well, as AstraZeneca announced it would submit Ultomiris to regulators in post-haematopoietic stem cell transplantthrombotic microangiopathy, although the drug missed the primary endpoint in a Phase III trial (NCT04543591).
Ultomiris was also a big seller for AstraZeneca in its most recent quarter, with the drug’s global revenue ballooning 17% compared with the same time last year to $1.4bn.
Currently, analysts at GlobalData, parent company of Clinical Trials Arena, foresee a healthy financial future for Ultomiris, as they expect the drug to bring in sales north of $6.3bn in 2032.
