Initiation Of Phase III Clinical Trial Of BAN2401 In Early Alzheimer's Disease

Eisai Launches Confirmatory Late Stage Trial Of Second Alzheimer's Asset After Setback

Why do companies, such as Biogen and Eisai, still spend billions of dollars attempting to bring through treatments when the success rate is so low?

The two halted trials were in the final stages of testing aducanumab in patients with mild cognitive impairment due to Alzheimer's and mild Alzheimer's disease dementia.

It was so promising that the company was running two phase three trials simultaneously, said neurologist Dr. Richard Isaacson, who directs the Alzheimer's Prevention Clinic at Weill Cornell in NY. After discussion with regulatory agencies based on the results of a Phase II clinical study (Study 201), a single Phase III clinical study is being initiated to support a filing for BAN2401.

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

Successful completion of these late-stage studies would have been a boon for Biogen as there are only a few treatments approved for Alzheimer's.

The development will raise questions about Biogen's future. One of them is Allergan's Namenda.

Without its potential blockbuster Alzheimer's drug, Biogen now needs "a more aggressive business development approach to de-risk and diversify" its pipeline, said RBC Capital Markets analyst Brian Abrahams in a note to investors on Thursday.

The Cambridge biotech company Biogen announced Thursday that it is scrapping tests on an experimental treatment for Alzheimer's disease, dashing hopes among advocates and caregivers for a medication to tame the devastating illness. Drugs that looked promising in early tests have come up short when tried in larger groups, frustrating pharmaceutical executives, doctors and patients.

Aducanumab was targeted at soluble beta amyloid, and some researchers now think that neurotoxic amyloid beta aggregates - which are the target for BAN2401 - are in fact the key driver of AD pathogenesis. Swiss drugmaker Roche Holding is continuing to pursue its own drug targeting beta amyloid, persisting despite setbacks. This study used Bayesian Adaptive Randomization Design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. After its candidate, gantenerumab, failed an earlier test four years ago, Roche made a decision to ratchet up the dose and try again with a pair of big late-stage trials. Roche's partner on the second compound, Alzheimer's specialist AC Immune, at one point fell more than 12 percent in premarket trading in NY.

BAN2401 and elenbecestat are being jointly developed by Eisai and Biogen Inc.



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