The phase II trial confirms the safety, tolerability and solid immune response of the compound from Araclon Biotech, from the Grifols Group.
The results of the phase II trial support continuing with the clinical development of the active vaccine against peptide A40 for the treatment of Alzheimer’s disease (AD) in the early phase, called ABvac40 and from Aragon’s Araclon Biotechfrom the Grifols Group.
This study has not only confirmed the safety, tolerability and strong immune response of what could become the first Spanish vaccine against this growing neurological disease but has also slowed the progression of the disorder by up to 38%, compared to placebo. By specifically targeting the amyloid peptide A40, ABvac40 is harnessing a central mechanism, thought to drive cognitive decline, with potential to alter the course of the disease.
According to information from Araclon Biotech about this trial (multicenter, randomized, double-blind and placebo-controlled, and carried out in 23 centers in the European Union), no cases of inflammation or aseptic meningoencephalomyelitis were reported in the treatment group, and there were few cases of microbleeds, comparable to placebo, and none that led to treatment discontinuation.
Other relevant results of phase II are that the neuropsychological tests, such as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) or the Trial Performance Test (TMT), showed favorable results in ABvac40 compared to the placebo group. The global or functional scales showed no differences between the two groups. And with volumetric MRI, an increase in brain atrophy was observed in the ABvac40 group compared to placebo.
Mercè Boada, medical director of the Ace Alzheimer Center in Barcelona and principal investigator of the phase II study, highlighted to this newspaper that the safety of this vaccine “is fantastic”, and that there has been no “nor aseptic meningoencephalomyelitis“. And he assured that “the immune response is very important; It drops when the vaccine is stopped, but after 10 months it is separated from the placebo and, with the booster dose, the peak response is very high and is maintained until almost 24 months. That indicates that it is immunizing.” He also pointed out that there is still find the most appropriate dose and in what period the recall would have to be done to maintain immunity.
Targeted to the C-terminal end of the A40 peptide
José Terencio, CEO of Araclon Biotech and Vice President of Innovation and New Technologies at Grifols, has stated, also in statements to this newspaper, about why with ABvac40, unlike what has been observed in other Alzheimer’s vaccines, there would be a risk. low meningoencephalitis, which “has a unique design targeting the C-terminal end of the A40 peptide. We believe this may improve the safety profile of the vaccine and prevent the formation of antigen-antibody complexes on cell membranes. On the other hand, the hapten used does not contain the epitope that has been described as responsible for meningoencephalitis, a complication observed in previous vaccines against Alzheimer’s disease. “In fact, this safety profile has been confirmed as part of the Phase 2 trial data.”
Regarding why they consider the immune response robust, he answered: “Because we see a significant increase in specific antibodies against A40, which also increases with successive doses and increases again when a booster dose of the vaccine is administered. The data in this sense is very clear. “What we also observed is that the levels of the A40 peptide in plasma are affected, correlating with the increase in specific antibodies against A40.”
These results seem to support the launch of the phase III trial, something about which Terencio has said that “we are very satisfied with the data obtained to date, including the solid immune response observed, accompanied by a reduction in worsening in some tests neuropsychological effects compared to what was observed with the placebo group. However, given that the study was not designed to look at clinical efficacy one cannot be conclusive in this regard, and all this with a favorable safety profile. We believe that these results validate the clinical potential of ABvac40, positioning it as a promising therapeutic candidate for the early treatment of Alzheimer’s disease, especially in patients with amyloid load at the vascular level given that the A40 peptide has been described as the main component of the vascular amyloidosis. “At this time we cannot provide more details as we are evaluating the next steps of the program.”
More interest in early detection
Mercè Boada also participated in the phase III studies -Graduate I and II- of the gantenerumabfrom Roche, an anti-beta-amyloid antibody designed for subcutaneous administration in patients in the early phase of Alzheimer’s disease, for which the ABvac40 vaccine is also directed.
The neurologist has highlighted the importance of early detection, which will be further enhanced by effective therapies at the onset of the disease. The time that passes from when the patient and family consult for suspicion of a neurological problem until the response arrives confirming Alzheimer’s is a 14 month average; “and that is already a great success.”
But it must be reduced much more, he has defended, making the population suspect a possible Alzheimer’s in the same way that they already do with breast cancer when faced with “a small lump in the chest” or colorectal cancer when faced with “a trickle of blood in the stool.” “; and also with a greater involvement of the family doctor. The latter is believed to make it easier for there to be approved therapies to prevent the disease from progressing.
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2023-11-26 15:08:05
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