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Biogen Inc (NASDAQ:BIIB) Exhibits New Data From LTE Of Phase 1b Trial Of Aducanumab

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Biogen Inc (NASDAQ:BIIB) will showcase new report from the long-term extension of its underway Phase 1b trial of aducanumab, the firm’s investigational cure for Alzheimer’s disease, at the CTAD meeting, Boston, from November 1 to November 4.

The highlights                                

The data comprise results from subjects in the Phase 1b trial who were cured with a gradually increased administration of aducanumab for up to 2 years and those who were cured with a fixed dose of 3 mg/kg, 6 mg/kg or 10 mg/kg aducanumab for up to 3 years. The results are consistent with initially announced analyses from the Phase 1b trial and support the design of the underway Phase 3 trials of aducanumab targeting early Alzheimer’s disease.

Alfred Sandrock, M.D., Ph.D., the Chief Medical Offer and EVP at Biogen, expressed that they now have up to 3 years of data from the Phase 1b trial of aducanumab and during this period they continued to witness decline of the biomarker, amyloid plaque. The data also indicate there is an advantage on clinical reduction for subjects in the Phase 1b trial, particularly at the highest doses of aducanumab. Their Phase 3 trials of aducanumab are underway to decide whether it may be a prospective treatment for early Alzheimer’s disease.

The Phase 1b trial is a randomized, placebo-controlled, double-blind, multiple-dose trial assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of aducanumab in people with mild Alzheimer’s disease or prodromal. This study comprises fixed dosing at 1, 6, 3 and 10 mg/kg and an arm with a titration plan in which subjects obtained a gradually increased administration of aducanumab until they achieve a maximum dose of 10 mg per kg.

In the Phase 1b long-term extension, the most commonly noted adverse events were headache, fall and ARIA. Of the 185 subjects administered with aducanumab in the Phase 1b trial, 46 subjects experienced ARIA-E. There were no new instances of ARIA-E in subjects who continued on the unchanged dose of aducanumab.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of journaltranscript.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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