Biogen Inc Aducanumab EMBARK study design and Q&A at CTAD 2020 Transcript
Good morning, good afternoon, good evening. My name is Carmen Castrillo, and I'm here to present the EMBARK study design. These are the disclosures [of the efforts], our forward-looking statements and our legal disclaimer.
I want to start by presenting the aducanumab program overview, which encompasses 7 studies, as you can see above: Phase I studies, including the Phase Ib PRIME study with its long-term extension; Phase II study EVOLVE that was started in 2018; and 2 Phase III studies, ENGAGE and EMERGE. As you all know, too, on March 2019, Biogen declared futility on the Phase III studies. And that decision and declaration impacted all ongoing studies, the 4 studies that you can see here and all studies came to a complete stop. After analysis of a larger dataset then that of the futility analysis, Biogen found that there were positive results in EMERGE. And that prompted the company to commit to restart aducanumab dosing in the patients that were impacted.
What is the rationale for EMBARK
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