Alzheimer's drug trial altered after nine deaths

DRUG FIRM Elan has halted elements of a clinical trial on an experimental treatment for Alzheimer’s disease after nine patients died.

Elan and its partner in the programme, Toronto-based Transition Therapeutics, announced yesterday they were halting two of three dosage levels of the new drug, ELND005, immediately following serious side-effects in some patients, including the nine deaths.

About 350 patients had been enrolled in the Phase II trial which saw separate groups receive twice-daily oral doses of 250mg, 1000mg or 2,000mg since October 2008.

In a statement yesterday, Elan and Transition Therapeutics said: “Patients will be withdrawn immediately from the study in the two higher-dose groups.”

It said the clinical trial would continue for patients on the lowest dosage level.

“The decision by the companies . . . was made in concurrence with the Independent Safety Monitoring Committee following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses.”

The companies stressed that no direct link between the drug and the fatalities had been established.

Elan’s chief medical officer and head of global development Menghis Bairu said the decision “speaks to our strong commitment to patient safety while allowing for the continued evaluation of the . . . 250mg dose.”

Shares in Elan did not react much, with analysts noting that little value had yet been priced in to the shares for the joint venture programme. However, Transition Therapeutics saw its stock spiral downwards by more than 40 per cent in New York and Toronto.

Jack Gorman of Elan’s broker Davy said the move “considerably raises the perceived risk of ELND005 reaching the market”.

“At the very least, the efficacy of the lower dose will need to be compelling to justify development and ultimate approval.”

Elan and Transition Therapeutics have been working together on the treatment since September 2006. Elan paid $15 million over two years as part of the agreement, before sharing costs with Transition. The Canadian group stood to receive up to $185 million from Elan subject to the development, regulatory approval and sale of the drug.

Following the recent deal with Johnson Johnson, which saw Elan surrender control of its Alzheimer’s drug development joint venture with Wyeth/Pfizer, the Transition Therapeutics joint venture is its most advanced Alzheimer’s programme. It is expected to report first results in mid-2010.

“This is a considerable blow for the progress of the drug,” Goodbody analyst Ian Hunter wrote yesterday in a note to clients. “This is a setback for Elan in terms of pipeline development and longer-term potential and will affect the sentiment on the stock.”

The news is another blow for the Irish group, which has recently had to change the labelling on its key multiple sclerosis drug Tysabri after a sharp increase in fatalities among patients.