BioPharma

Biogen’s Alzheimer’s disease drug crashes in Phase III testing

The news sent Biogen's shares down more than 26 percent pre-market, but analysts also wrote that it deals a significant blow to amyloid beta as a target in Alzheimer's disease.

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

Shares of biotech giant Biogen were down sharply in pre-market trading as the company announced the failure of its leading drug for Alzheimer’s disease.

Cambridge, Massachusetts-based Biogen – together with its development partner, Japanese drugmaker Eisaisaid Thursday morning that they were discontinuing the Phase III ENGAGE and EMERGE studies of aducanumab in mild cognitive impairment and dementia due to Alzheimer’s. The decision was based on results of an independent data monitoring committee’s futility analysis, which indicated the trials were not likely to meet their primary endpoint. Extensions of earlier-stage studies were also halted.

Shares of Biogen were down more than 26 percent pre-market on the Nasdaq following the news.

“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,” Biogen CEO Michel Vounatsos said in a statement.

Aducanumab belongs to a drug class targeting amyloid beta, based on the hypothesis that accumulation of the peptide is the primary cause of Alzheimer’s disease, making it the main focus of Alzheimer’s research over the last 20 years. But it hasn’t been without controversy, as all efforts to develop drugs targeting amyloid beta have been futile. Now, that string of failures includes aducanumab.

Analysts from SVB Leerink wrote that they anticipate that Biogen’s stock will likely fall to $240-260 per share – it closed at $320.59 Wednesday. However, analyst Geoffrey Porges and his team wrote, they “cannot find any near term catalysts that would help the stock recover back above $300.” Nevertheless, they wrote, they had given the aducanumab program only a 35 percent chance of success in their modeling, having many concerns regarding amyloid beta as a target given the failures of multiple monoclonal antibodies targeting the peptide in recent years.

Meanwhile, Cowen analyst Phil Nadeau agreed, adding that the announcement removes the biggest potential opportunities from Biogen’s pipeline. He further wrote that aducanumab’s clear ability to remove amyloid beta from the brain in Phase Ib testing made it hard to see how other monoclonal antibodies with the same target – including Biogen’s own BAN 2401, currently in Phase II studies – could succeed. “Therefore, [Biogen] is unlikely to get any credit for BAN 2401 unless and until it can produce positive Phase III data,” he wrote.

According to a 2017 paper in the journal Expert Opinion on Investigational Drugs surveyed discontinued drugs for Alzheimer’s disease from between 2010 and 2015. These included bapineuzumab, developed by Pfizer and Johnson & Johnson’s Janssen subsidiary, and Eli Lilly & Co.’s solanezumab. In both cases, the drugs failed in randomized Phase III clinical trials despite previously showing efficacy in prior studies.

Photo: wildpixel, Getty Images

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