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Lilly sinks as solanezumab fails again in Alzheimer's

Amyloid-targeting drug showed no significant evidence of slow in cognitive decline

Eli Lilly's solanezumab was unable to show a benefit in the much-anticipated EXPEDITION3 trial in mild Alzheimer's diseases, adding to a litany of failures for amyloid-targeting drugs.

Patients treated with solanezumab in the trial showed no significant evidence for a slowing in cognitive decline compared to those on placebo, and Lilly's chief executive John Lechleiter confirmed that the company will not be seeking approval of the drug for mild Alzheimer's disease.

Lilly said the trends "directionally favoured" solanezumab but the "magnitudes of treatment differences were small", a finding reminiscent of the results of the EXPEDITION1 and EXPEDITION2 trials in more advanced disease in 2012.

The results "were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease," said Lechleiter, who will retire at the end of the year.

Lilly had been positive about the prospects for solanezumab as recently as a few weeks ago, when CEO-in-waiting David Ricks said showing no benefit compared to placebo was the "least probable outcome" from the trial.

Now, the company says it will discuss the data with experts in Alzheimer's dementia before it takes a decision on the future of solanezumab – which recently started a phase III trial in 'prodromal' patient's in the earliest stages of the disease due to report results in 2021 – as well as other pipeline projects such as its AstraZeneca-partnered BACE inhibitor AZD3293.

Ricks has previously suggested that if EXPEDITION3 was a bust then the expensive, 2,500-patient prodromal trial will probably be abandoned. Lilly said it would take a $150m charge on the fourth quarter as a result of dropping solanezumab but is thought to have spent billions developing the drug to date.

"This result will no doubt cast a shadow over Lilly's Alzheimer's disease pipeline portfolio, which is heavily based on the beta amyloid hypothesis," said analysts at Leerink in a research note.

Shares in the company fell more than 15% yesterday as investors considered the implications for the company and – more importantly – the array of amyloid-targeting compounds also in development for Alzheimer's disease. One of these – Biogen – saw its shares fall nearly 10% on fears that the result could affect its candidate aducanumab.

The results undermine once again the notion that amyloid beta is the main pathogenic factor responsible for the degenerative changes that occur in the Alzheimer's brain. Antibodies that directly target amyloid, small-molecule BACE inhibitors designed to interrupt its production, drugs that block aggregation into plaques and immunotherapies are all in late-stage development.

Leerink is staying cautiously optimistic, pointing out that Biogen's drug showed greater activity than solanezumab in a phase Ib trial and that its ongoing phase III study "has a different patient population (milder disease), more rigorous confirmation of amyloid and uses a much higher dose of antibody and different endpoints".

Article by
Phil Taylor

24th November 2016

From: Research



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