Drug Development

FDA clears a Phase III path for Biogen’s BACE drug for Alzheimer’s

Biogen has taken another step forward in prepping a Phase III program for its BACE drug for Alzheimer’s, with its partner Eisai noting that the FDA has signed off on the late-stage program. The plan now is to get regulators in Japan and Europe to offer a green light as well and run it as a global registration study.

E2609 was one of two drugs that Biogen partnered on with Eisai back in the spring of 2014. BAN2401 was also included as Biogen traded off development rights on aducanumab (BIIB037) and an anti-tau approach. Now investigators will take the high 50 mg dose of E2609 into Phase III studies.

Biogen is following a wide trail littered with clinical failures. It experienced its own setback on aducanumab a year ago, after a 6 mg dose failed to improve on the performance of the 3 mg dose, raising fears that there was no dose-dependent response to track. None of that stopped Biogen from advancing the drug into Phase III, though, and several top investigators in the field have been enthusiastic about preliminary signs that the amyloid beta drug could actually work against the memory-stealing ailment that afflicts millions.

Merck already has a Phase III BACE drug, which moves upstream to prevent the production of amyloid beta with a beta-secretase cleaving enzyme. Clustered together into toxic tangles, the theory is that Alzheimer’s is triggered by amyloid beta, though there is no scientific consensus on that point. AstraZeneca, meanwhile, sold their BACE drug to Eli Lilly in a partnership deal.

Biogen is swinging for the fences with its lineup of Alzheimer’s drugs in the clinic. The disease has repeatedly defeated every major drug effort designed to slow progression, with Lilly and J&J/Pfizer on the losing end of two big amyloid beta drugs. While Lilly has a new effort underway for Alzheimer’s, it recently changed the endpoints on the new solanezumab Phase III in what is widely seen as a preliminary move aimed at persuading the FDA to accept a compromise with a primary focus only on cognition.

TauRx, an offbeat Singapore-based biotech, recently experienced its own setback with a Phase III failure for its approach on tau, another toxic player implicated in Alzheimer’s.

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