Biogen, Eisai scrap late-stage studies of aducanumab in Alzheimer's disease as deemed unlikely to hit main goals

Biogen and Eisai said Thursday that Phase III studies of the experimental anti-amyloid beta antibody aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia will be halted as they are unlikely to meet their primary endpoints. "This disappointing news confirms the complexity of treating Alzheimer's disease," remarked Michel Vounatsos, CEO of Biogen, whose shares plunged more than 27 percent in reaction to the update.

Commenting on the news, RBC Capital Markets analyst Brian Abrahams said the development is a "transformative failure for Biogen's pipeline." Meanwhile, Guggenheim analyst Yatin Suneja said the outcome was "investors' worst fears come true," adding "while unfortunate, we are not particularly surprised as numerous AB-targeting compounds have failed to demonstrate benefit in Alzheimer's patients, and, in our view, this trial may signal the end of the current AB hypothesis of Alzheimer's aetiology."

Biogen and Eisai said that they will halt the late-stage ENGAGE and EMERGE trials on the recommendation of an independent data monitoring committee following a futility analysis, adding that the decision to stop the studies was not based on safety concerns. The primary objective of the trials was to evaluate the efficacy of monthly doses of aducanumab versus placebo in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes score.

Meanwhile, the companies also indicated that the EVOLVE Phase II study and the long-term extension of the PRIME Phase Ib trial of aducanumab will be discontinued. Biogen and Eisai added that the initiation of a Phase III secondary prevention trial for aducanumab will be assessed while the data from ENGAGE and EMERGE are evaluated. Biogen licensed aducanumab, also known as BIIB037, from Neurimmune.

If successful, expectations for aducanumab had been high, with analysts at Goldman Sachs one time forecasting that sales of the drug could reach $12 billion. "This was the largest opportunity and the most high-profile pipeline event for trial events in the entire space, you could argue, let alone for Biogen," remarked Jefferies analyst Jared Holz. "We've been talking about this for several years with an expectation we'd get a readout in 2020. There was obviously a chance you could have a futility analysis in 2019, but investors thought we were past that point," Holz added.

Holz commented that following the slump in Biogen's shares, "all you are left with now is a value stock – it's essentially Gilead [Sciences], a cheap stock with an unproven pipeline and a company that will be more reliant on M&A." SVB Leerink analyst Geoffrey Porges added "we cannot find any near term catalysts that would help [Biogen's stock recover."

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