Aducanumab, a clinical treatment drug, primed to treat those with early symptoms of Alzheimer’s, recently went into Phase 1B clinical studies trial. Recently, the firm responsible for the manufacturing of the clinical treatment drugs, Biogen Inc. (NASDAQ:BIIB) released the data obtained from the Phase 1B trial.
The data will be presented at the 9th clinical trials on Alzheimer’s disease (CTAD) meeting, which is scheduled to take part today, in San Diego. The presentation will allegedly contain information extracted from the clinical trial phase 1B, as well as information retaining to the long-term extension, from the first-year data.
According to those familiar with the matter, the presentation, will provide supplementary proof, that the drug is ready for the ongoing Phase 3 studies of aducanumab treatment for early symptoms of Alzheimer’s.
How the Phase 1B studies work
There are specific implementations of the Phase 1B clinical trial, no matter the drug involved. Generally, it is a randomized, double-blind, multi-dose studies to various studies and effects on the drug.
In the question of the aducanumab, various aspects were taken into consideration such as the safety, tolerability, clinical effects of the drug on patients suffering from prodromal (mild) Alzheimer’s. Other things evaluated during this trial, include aspects such as pharmacokinetics, as well as pharmacodynamics.
In the Phase 1B, the following doses of drugs are administrated, the first n=31., 3 (n=33), 6(n=30). Furthermore, there is also an arm of a titration regimen (n=23) as well as a pooled placebo (n=48).
For those who are not aware of what is meant by A.R.M., This is the acronym for amyloid-related imaging abnormalities. In the trial, it was found that rates of ARIA were higher in carriers than that of non-carriers.
Further development of Aducanumab
Following the successful trial run of Phase 1B for aducanumab, the drug will proceed to be evaluated in Phase 3 studies, two to be precise. Both of these studies are designed to evaluate the safety and efficiency of the drug in question. Furthermore, the analysis will evaluate the hindering of progression, for those who are suffering Alzheimer’s.