The Aragonese vaccine against Alzheimer’s, in which development has been working since 2014, continues to have a promising future after phase II trials have yielded results confirming a “excellent safety profile and tolerability”. In addition, according to sources from the company Araclon Biotech, based in Zaragozait has been found “an elevated immune response” in patients with mild cognitive impairment and in those with very mild Alzheimer’s.
Araclonwhich belongs to the Grifols group, has been in charge of design the ABvac40, What is the name of the Alzheimer’s vaccine? His forerunner was the ayerbense researcher Manuel Sarasawho passed away two years ago and who was the one who founded the Araclon laboratories.
Recently, data from phase II, in which 124 patients, have been “satisfactory” and guarantee the continuity of the trial, but from the company they could not specify to this newspaper when phase III will begin, which would already be the last.
Initially, the safety of the vaccine seems guaranteed because phase II has ratified that certainty. “There were no significant differences between participants in the group receiving ABvac40 and those in the placebo group. These data confirm those obtained in phase I, whose results were presented in July 2016, evidencing a good safety profile“, detailed from the company.
Regarding efficacy (immunogenicity), the administration of 6 doses of the inoculation “produced a significant increase” in the levels of specific antibodies higher than those observed in the phase I trial, when three doses were used. Beta-amyloid proteins 40 (ab40) and 42 (ab42) are associated with the risk of Alzheimer’s. “The dose induces a strong immune response characterized by an increase in anti-Ab40 titers in parallel with an increase in Ab40 levels in plasma,” said José Terencio, CEO of Araclon and Vice President of Innovation at Grifols. Now, the next phase will be IIb and, according to its results , it will be passed before or not to phase IIIalthough there are no estimated deadlines.
For some time now, Araclon Biotech has also been working on seek solutions for early diagnosis of Alzheimer’s through tests, known as the ABtest-MS test. This accurately identifies those patients with cerebral amyloid burden, a sign indicative of Alzheimer’s in very early stages. His detection would facilitate early management of the disease.
“The predictive ability of this test makes it suitable for detecting early stages and accelerate recruitment for clinical trials of new treatments, thus reducing the rate of screening failure and associated costs,” said Terencio.
ABtest-MS is a “unique” method and is fully developed by Araclon. Its results include a two-year follow-up study that confirms how the test can predict brain amyloid loadl in patients with subjective memory deficits. “The data corresponding to 5 years of follow-up of said cohort are currently being analyzed,” they added from the company.
On the other hand, they have also carried out a multicenter study in more than 50 centers where it has been possible to predict “accurately” the brain deposition of amyloid protein in plasma samples from 731 subjects. “It has confirmed the suitability of using a centralized and extensively validated method such as ABtest-MS in these large and heterogeneous studies of patients,” Terencio said.