An experimental Alzheimer’s medicine has flunked a large clinical trial, wiping more than $10bn off the market value of its developer Eli Lilly and dealing a significant setback to the hunt for a drug to delay the fatal disease.
Investors and analysts had tipped the medicine, known as Solanezumab, or Sola, to be the first drug that could delay dementia in Alzheimer’s patients, after earlier studies appeared to show it slowed the rate of cognitive decline in patients with mild forms of the disease.
The failure of Sola is also a blow to the most widely accepted theory of what causes Alzheimer’s: the so-called amyloid hypothesis, which holds that the brain stops functioning properly because it becomes covered in a sticky plaque known as amyloid.
In recent decades scientists have focused their efforts on drugs that reduce amyloid, and drugmakers have spent billions of dollars developing new medicines designed to remove the plaques — even after a succession of high-profile failures.
Eli Lilly is testing several other drugs aimed at clearing amyloid from the brain while rival medicines are being used in late-stage studies by a clutch of competing drugmakers including Biogen, Roche, Johnson & Johnson and Merck in the US.
“This result will no doubt cast a shadow over Lilly’s Alzheimer’s pipeline portfolio, which is heavily based on the amyloid hypothesis,” said Seamus Fernandez, an analyst at Leerink.
He added: “Other competitors’ programs based on this hypothesis will probably continue, but this will likely have negative read-through on these results in the short term.”
The feeling of gloom among pharmaceuticals investors was compounded by the news that trials of another closely watched treatment had to be halted following the death of several patients on the study.
More than $1bn was wiped from the market value of Juno after the biotech company revealed it had suspended a clinical trial of its experimental cancer therapy for the second time in five months following the death of two further patients, bringing the total number of fatalities to six.
In an interview before the Sola data were published, Dr Martin Farlow, a leading neurologist, said an outright failure would be damaging for the field and could deter investors from backing other medicines designed to reduce amyloid.
“It’s a very well-organised test of the amyloid hypothesis with a convincing number of patients, so in that sense I think it would be received very badly,” said Dr Farlow, who was one of the doctors investigating Sola.
Eli Lilly said the results from the trial of 2,000 participants, “directionally favoured the drug, [but] the magnitudes of difference were small”. It said it had no plans to seek regulatory approval for the medicine.
Dave Ricks, who will take over as Eli Lilly chief executive in January, said: “Obviously the people closest to the programme are really disappointed. This is not going to be a disease-modifying therapy, and that is heartbreaking.”
Shares in Lilly lost 12 per cent in early trading in New York, wiping more than $10bn from the group’s market capitalisation.
Biogen, which is developing a rival medicine, fell 6 per cent, even as some analysts argued, somewhat implausibly, that the failure of Sola was good news for the biotech group.
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