On Friday Grifols presented the results of its AMBAR (Alzheimer Management by Albumin Replacement) (phase IIb/III) study at the “Clinical Trials on Alzheimer ́s Disease” (CTAD) Congress in Barcelona. AMBAR is an innovative possible treatment based on the therapeutic properties of plasma which has shown, statistically significantly, its effectiveness in slowing the progression Alzheimer in moderately affected patients. The combination of the extraction of plasma through plasamapheresis (an established and safe technique which is used in plasma replacement) and its replacement with Albutein® 20% (albumin, a safe and well tolerated plasma protein with multiple therapeutic properties) has shown a significant slowing of the disease in patients moderately affected who have participated in the study, offering a possible alternative treatment of Alzheimer. The results in the population of patients with moderate Alzheimer in the trial have shown, with statistical significance, a slowing of the progression of the disease in 61% of a sample of 496 patients, and achieves the two principal objectives of effectiveness established: cognitive improvement and improved capacity to carry out daily activities during the 14 months of the treatment. In the group of patients with light Alzheimer the results also suggested a slowing in the progress of the disease (a similar performance is observed in the control group) although the difference is not statistically significant.
The company of blood derivatives believes its therapy “could have immediate application”, but market analysts are generally more cautious. Alphavalue analysts say their caution is because these studies often have a high level of mistakes and Morgan Stanley analysts argue that the lack of statistical significance in some of the results invites caution until we see the better breakdown of the results next year.