Grifols SA's Alzheimer's therapy helped reduce neuronal damage in patients, additional neuroimaging data from a phase 2b/3 study showed.
The Spanish drugmaker's therapy involves separating the plasma from a patient's blood — a process called plasmapheresis — and replacing it with Albutein, or albumin, a plasma protein.
In the study called Alzheimer Management by Albumin Replacement, or Ambar, Grifols enrolled patients with mild and moderate Alzheimer's disease. Based on the results, patients treated with Grifols' therapy had less reduction of brain glucose metabolism during the 14-month Ambar trial.
The additional findings presented by Grifols also cover the study's secondary goals, which measured improvements in memory and quality of life of patients with moderate Alzheimer's, and language and processing speed for those with a mild stage of the disease.
At 14 months of treatment, patients who received the therapy demonstrated a 71% reduction in clinical decline compared to placebo. Grifols measured clinical decline by evaluating memory, orientation, judgment, community affairs, home and hobbies, and personal care of the patients.
The Spanish company also noted stabilization in all treated patients after examining several domains of cognition, daily functioning and behavior.
In October 2018, Grifols presented results that showed a 61% reduction from baseline in disease progression — measured through changes in cognition and in daily living activities scores — in the patients after 14 months, Ambar's primary efficacy goals.
Alzheimer's disease, an ailment that has long stumped researchers and drug developers, causes a progressive decline in memory and cognition. Though the Alzheimer's disease drug pipeline has been riddled with failures, Barcelona-based Grifols is one of the companies vying for what would be a massive reward, as an estimated 74.7 million individuals worldwide will develop the disorder by 2030.
Barcelona-based Grifols plans to discuss Ambar's results with the U.S. Food and Drug Administration and the design of the next Ambar II trial.