POSITIVE TOPLINE RESULTS OF THE FINAL ANALYSIS FOR BAN2401

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ru442
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POSITIVE TOPLINE RESULTS OF THE FINAL ANALYSIS FOR BAN2401

Post by ru442 »

Biogen press release:

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Re: POSITIVE TOPLINE RESULTS OF THE FINAL ANALYSIS FOR BAN2401

Post by NF52 »

ru442 wrote:Biogen press release:
Thanks for posting this. The details are encouraging to this non-scientist; especially for those dealing with a diagnosis of MCI or early AD. Here's the summary, with key details highlighted (by me). Note that ApoE 4 participants had some ARIA (edema) which has been seen on other studies. Since this study wasn't cancelled, it may have been minor and not shown any long-term impact.

Of course, it bears repeating that many drugs have shown promise in Stage 2 trials, then proved either not statistically significant or significant but with serious adverse effects in Stage 3 trials. Hope springs eternal, though...

I would expect that BAN2401 will move to Stage 3 Clinical Trials as soon as possible. Since they had 118 locations across the U.S. for this Stage 2 trial, they should have the infrastructure to secure IRB approvals more quickly than an initial start-up.

For those interested in the possibility of a new trial being at a nearby location, here is a link to the Clinical Trials page with the current (closed) trial locations : A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease-Locations
Study 201 (ClinicalTrials.gov identifier NCT01767311) is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's dementia (collectively known as early Alzheimer’s disease) with confirmed amyloid pathology in the brain. Efficacy was evaluated at 18 months by predefined conventional statistics on ADCOMS, which combines items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog), the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale and the Mini-Mental State Examination (MMSE) to enable sensitive detection of changes in early AD symptoms. Patients were randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo.

Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) as compared to placebo. Results of amyloid PET analyses at 18 months, including reduction in amyloid PET standardized uptake value ratio (SUVR) and amyloid PET image visual read of subjects converting from positive to negative for amyloid in the brain, were also statistically significant at this dose. Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints. Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months.

BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA). Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E (edema) was not more than 10% in any of the treatment arms, and less than 15% in patients with APOE4 at the highest dose per the study protocol safety and reporting procedures.

Detailed results of the study will be presented at future academic conferences.
POSITIVE TOPLINE RESULTS OF THE FINAL ANALYSIS FOR BAN2401
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Re: POSITIVE TOPLINE RESULTS OF THE FINAL ANALYSIS FOR BAN2401

Post by Orangeblossom »

Interesting, looks worth keeping an eye on doesn't it. Wondered what caused the edema.
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