Elan, Transition Move Alzheimer's Drug Into Final Stage of Clinical Trials
Elan Corp. and Transition Therapeutics Inc. said their experimental Alzheimer’s disease treatment will progress into the last stage of human tests even as the drug failed to meet an interim study’s main goals.
Elan, Ireland’s largest drugmaker, and Transition will continue to test the drug, ELND005, in patients with mild to moderate forms of the disease, the companies said in a statement. They will also “explore all strategic, operational and global options” for the therapy, they said.
In December, Dublin-based Elan and Transition, based in Toronto, halted two arms of the study after nine deaths and “serious adverse events” occurred for patients on higher doses. The findings, announced late yesterday, were based on 166 patients who took the lowest dose of the drug or a placebo for as long as 18 months. The therapy failed to significantly improve patients’ mental status or daily living activities, the main goals of the trial.
“We’re moving forward,” Elan spokeswoman Miriam Mason said today in an interview. “It’s a very complicated field.”
Elan gained 0.1 percent to 4.05 euros at 5:10 p.m. in Dublin trading.
“The market is pleased they are moving it into phase 3,” Ian Hunter, an analyst at Goodbody Stockbrokers, said in an interview. “And that they’re looking for a partner to help bring it through the system to share the risk. It has potential. Alzheimer’s involves very large, very expensive trials.”
Paying Off Debt
Elan also announced today that it will pay off about $500 million in outstanding debt that was due to mature in November 2011 and November 2013. First-half adjusted earnings before interest, tax, depreciation and amortization increased to $82.4 million from $13.1 million in the prior-year period, Elan also said today.
An estimated 18 million people worldwide have Alzheimer’s disease, and those numbers are expected to reach 34 million by 2025, according to the World Health Organization. The disease is the most common form of dementia in older people. There’s no cure for Alzheimer’s, although some drugs such as Eisai Co.’s Aricept temporarily ease symptoms.
Elan and Transition’s study results were from the second of three phases of clinical trials generally required to gain U.S. regulatory approval for a new drug. No timetable has been set for announcing the next steps in ELND005’s development, the companies said.
In the patient group receiving a lower-dose of ELND005, one death was reported compared with none among those who received a placebo, the companies said. Serious side effects considered to be drug-related were 2.3 percent in the ELND005 group and 2.4 percent in the placebo group, the companies said.
Falls, depression and a “confusional state” were among the side effects reported in at least twice the rate of patients who took the experimental drug compared with those on the placebo, the companies said.
An independent committee reviewing safety concluded that “a causal relationship between the deaths and drug cannot be determined,” Elan and Transition said.