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Araclon Biotech, a Grifols Group company dedicated to the research and development of therapies and diagnostic methods applied to degenerative diseases, will present topline results for the first part of its phase II clinical trial on its active immunotherapy, ABvac40, against Alzheimer's Disease, or AD, as well as data on two studies of its assay, ABtest-MS, to identify early-stage AD. Regarding the vaccine ABvac40, the principal data analyzed until now are satisfactory in that they support the continuation of the trial's extension phase. Researchers have confirmed that the vaccine shows a safety and tolerability profile, in addition to demonstrating a high immune response in patients with amnestic mild cognitive impairment or very mild AD. This multicenter, random and double-blind phase II trial included a total of 124 patients with aMCI or very mild AD and were divided evenly between the treated group and the control group. As far as the primary objective of safety, there were no significant differences between the participants in the group that received ABvac40 and those dosed with the placebo, including incidences of ARIA-H. No ARIA-E events were reported during Part A of the study. These data confirm those obtained in phase I and presented in July 2016, which showed a safety profile. In addition, Araclon Biotech continues with its research focused on the development of solutions to detect AD in its early stages. Diverse studies confirm the high predictive ability of its assay ABtest-MS to identify precisely those subjects with cerebral amyloid load, a sign of early-onset AD, which would enable management of the condition in its initial phases. ABtest-MS, a method developed entirely in Araclon and based on the mass spectrometry technique, is capable of accurately quantifying amyloid 40 and 42 proteins - both associated with the risk of having AD - in plasma samples. The results to be presented at the AD/PD 2022 Conference are centered on two recent studies. Data from the trial conducted on the FACEHBI cohort, obtained after two years of follow up, confirm the potential of the ABtest-MS to predict the cerebral amyloid load, an initial sign of AD, in individuals with subjective memory complaints and the potential that the analysis of these markers have as an indicator of how the condition evolves. The data corresponding to five years of follow up with the cohort are currently being analyzed. In the second study, the multicenter A4 Study[3] carried out in 50 centers, the ABtest-MS predicted the cerebral deposit of the amyloid protein in plasma samples from 731 subjects. It also confirmed the suitability of utilizing a centralized and extensively validated method such as this assay in these broad and heterogenous studies. These data confirm other results previously obtained on more than 1,000 subjects in different AD stages from various international cohorts that have been recently featured in scientific publications such as Alzheimer's Research & Therapy, Nature Aging and Alzheimer's & Dementia: The journal of the Alzheimer's Association, confirming the relation between amyloid biomarkers in plasma and AD. With respect to the other primary objective, efficacy, the administration of six doses of ABvac40 resulted in a significant increase in the specific antibody levels, greater than those observed in the phase I trial. This phase II evaluates as secondary efficacy variables changes in the disease's biomarkers, as well as in cognition and the quality of life resulting from ABvac40. The study's Part B is progressing according to plan.

Grifols announced a collaboration with Endpoint Health, a precision-medicine therapeutics company dedicated to addressing urgent needs in immune-driven critical care, to develop and commercialize an Antithrombin III, or AT-III, therapy to treat Sepsis. As part of the agreement, Grifols will contribute its expertise in plasma-protein therapies and be the exclusive supplier of AT-III, a plasma protein that treats patients with blood clotting issues. As part of the collaboration, and subject to the FDA's acceptance of its IND and Investigational Device Exemption, or IDE, filings, Endpoint Health will deploy its AI technology and its proprietary diagnostic test in a phase II trial designed to identify septic patients mostly likely to respond to AT-III. Upon FDA approval, the companies will invest in a build-out of AT-III production at Grifols sites.