Elan cuts high doses in drugs trial

ELAN has ceased the two highest doses in clinical trials of one of its main Alzheimer’s treatments following the deaths of nine people, even though those deaths have not been directly linked to the trial.

While the Dublin and Athlone-based pharmaceutical company — best known for its multiple sclerosis drug Tysabri — took the decision to modify the trials, along with the Independent Safety Monitoring Committee (ISMC), it said “a direct relationship” between the drug, code-named ELN D005, and the deaths “has not been established”.

While it is uncertain as to what role the testing had in the deaths, it was felt that the highest doses — 2,000mg and 1,000mg both twice daily — showed a generally lower level of tolerability amongst patients. According to Elan, no concerns have been recognised in the test treatment of patients using the lower dose of 250mg twice daily. In all, 353 patients have been taking part in the latest trials, which will continue at the lower dosage level.

Elan’s chief medical officer and head of global development, Menghis Bairu, added: “The decision speaks to our strong commitment to patient safety, while allowing for the continued evaluation of ELN D005 at the 250mg dose, twice daily. We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELN D005 for the potential treatment of Alzheimer’s.”

The ELN drug is the second in line in Elan’s pipeline of treatments for Alzheimer’s, behind its main in-trial drug, AAB-001 (more commonly referred to as Bapineuzumab).

ELN D005 is currently in Phase 2 trials, which are mainly aimed at measuring drug safety. Final results from this phase of its trial process are expected next summer.

Elan’s share price was unaffected in early trading, yesterday. Indeed, it actually rose by 5c to €4.50 before lunchtime and closed at €4.53, up 1.79%.

“Given that it is in an 18-month Phase II trial, we had little value attached to the drug candidate and no revenue pencilled in over the next five years. However, this is a setback for Elan in terms of pipeline development and longer term potential and will affect the sentiment on the stock,” said Ian Hunter of Goodbody Stockbrokers.

As part of its strategic partnership deal with Johnson & Johnson, completed earlier this year, Elan sold an 18.4% stake in the company to the US healthcare giant, with J&J also receiving a 50.1% stake in the Irish company’s Alzheimer’s treatment pipeline.

Elan has around 10 different Alzheimer’s treatments at various clinical trial stage; in conjunction with different companies including Eli Lilly and Wyeth. The ELN D005 treatment is being developed alongside Transition Therapeutics.