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Biogen and Eisai claim mid-stage win for Alzheimer’s drug

Says drug slowed down progression of cognitive decline

Biogen

Biogen and Eisai say their amyloid-targeting drug BAN2401 appears to slow down cognitive decline in a phase II trial in Alzheimer’s patients – a rare win in a field littered with failed projects.

The results come from the final analysis of a very large, 856-patient study in people with early Alzheimer’s disease who have been treated with the anti-amyloid beta protofibril antibody for 18 months and, according to analysts at Jefferies, should prompt a phase III registration trial.

Shares in both companies leaped on the news, amid expectation that the drug might be able to affect the underlying cause of the disease.

Biogen and Eisai aren’t disclosing hard data just yet, but say BAN2401 achieved a statistically significant slowdown in the progression of cognitive decline, measured using the ADCOMS symptom scale, as well as reduction in amyloid deposits in the brain, at the 18-month timepoint. The trial didn’t meet its primary objective at 12 months, as reported last December. There is also evidence of a dose response on amyloid and cognition scores, with only patients on the highest dose (10mg/kg biweekly injections) faring significantly better than placebo.

The two companies say they will discuss the data with regulators to see how best to move forward, but its apparent they are excited by the results.

“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Eisai’s head of neurology Lynn Kramer, while Biogen’s chief medical officer Alfred Sandrock said the data “underscores that neurodegenerative diseases may not be as intractable as they once seemed.”

While the result still needs to be subjected to peer review and backed up in later-stage trials, it’s worth pointing out that other anti-amyloid antibodies such as Eli Lilly’s solanezumab were unable to show much more than a trend towards a positive effect on cognition scores in phase II, yet still advanced into late-stage testing only to fail at the final hurdle.

BAN2401 seems to be starting that process from a stronger position, and while it’s not uncommon that phase II results are a poor predictor of phase III efficacy, the scale of the latest study and use of a well-characterised endpoint stands in its favour.

In a research note, Jefferies says the result is “perhaps the ‘best case scenario’ for BAN2401 on pretty low expectations”, and will help ‘move the pendulum’ a little in favour of the amyloid hypothesis for Alzheimer’s disease. They estimate– based on Eisai’s earlier communications on the drug and trial design – that the clinical benefit could be around 20-25% and “certainly very clinically meaningful” if so.

Biogen now has two mid-stage trials with anti-amyloid drugs which appear to be positive in Alzheimer’s, with its aducanumab candidate also showing a statistically-significant improvements in cognition and beta-amyloid levels, backed up by a dose-response relationship, write the analysts.

The biotech was forced to enlarge the size of its phase III programme for aducanumab due to variability in responses, and results are now due in 2020.

“Specialists will certainly point to this supporting the bull thesis that [Biogen] is continuing to put up solid evidence of good probability for success on Alzheimer's,” they note. At the moment, they give the company a 50%-60% probability of success, but stress it will take time for the data to come in.

Article by
Phil Taylor

6th July 2018

From: Research

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