More Troubles for Elan

Nine deaths in an Elan-sponsored phase 2 trial of oral scyllo-inositol (aka ELND005 or AZD-103) in Alzheimer disease have led to the discontinuation of the highest-dose arms in clinical development. The cause (or causes) of the deaths was not provided in today's company press release or by news sources, like Reuters. The investigational drug is intended to prevent the buildup of amyloid in the brains of AD-affected patients.

According to the NIH registry, the trial (which is conducted in collaboration with Transition Therapeutics) is a randomized, double-blind, multicenter US and Canadian study that was comparing 3 doses of the experimental agent with placebo in more than 300 individuals with mild-moderate AD.* Elan states that the study completed enrollment in October; the study duration is 18 months (with results anticipated in May of next year, according to the NIH database). The discontinued dosages are 1000 and 2000 mg bid in both the blinded, phase 2 study and an open-label trial. All patients assigned to scyllo-inositol treatment will now receive the lowest dosage, 250 mg bid.

In August, Elan and Wyeth announced that the highest dosage of its anti-amyloid mAb, bapineuzumab, would be discontinued in 2 ongoing phase 3 studies of ApoE4 noncarriers (40%-70% of AD patients), because of the risk of vasogenic edema.

In September, JNJ closed its highly publicized buyout deal with Elan, in which JNJ acquires the rights to Elan's AD immunotherapy program (which Elan shared with Wyeth). The program includes the development of bapineuzumab but not scyllo-inositol.

A couple of previous Pathophilia posts about Elan's troubles:

• Despite Manipulation, Phase 2 Bapineuzumab Study Still Disappoints
• SEC Eyeballs Elan

mAb = monoclonal antibody.

* Approximately 353, per Elan.

Photograph: Atrophied brain from person with AD from National Institute on Alcohol Abuse and Alcoholism.