the mild patients, enough to spend more millions upon millions of dollars on a new trial, Expedition 3, for that population. Lilly announced earlier this year, in the middle of the trial, that it would turn one of the primary goals, the improvement of function in daily activities such as getting dressed, into a secondary goal. That leaves improvement in cognition as the only primary goal of the trial. Results are due in December.
Another Alzheimer’s antibody drug, crenezumab, showed disappointing Phase 2 results in 2014, but its owners Roche and AC Immune are pressing ahead with a Phase 3 study in less-afflicted patients.
There was more news from the meeting this week that involved silver linings. Privately held Alzheon said it has wrapped up a couple small studies that give it confidence it can start big Phase 3 trials in the first half of 2017 with its drug ALZ-801.
ALZ-801 used to be called tramiprosate, which failed a Phase 3 study nearly 10 years ago on someone else’s dime: a Canadian company called Neurochem. But Alzheon has revived it and raised $20 million to tweak its chemical formula. Framingham, MA-based Alzheon dug through the Neurochem data and found positive signals in a group of people with a specific genetic mutation, called ApoE4, on both sets of their chromosomes. (The mutation is linked to higher risk of Alzheimer’s, and the risk gets worse for double carriers.) Alzheon CEO Martin Tolar said he needs to raise $100 million, perhaps via IPO, to start Phase 3, a goal he outlined earlier this year, as well.
In other Alzheimer’s news this week, Anavex Life Sciences (NASDAQ: [[ticker:AVXL]]) presented Phase 2 data for its drug 2-73 and saw its stock crash. At the end of Thursday, shares in the New York company were down more than 50 percent since it said that patients after 31 weeks showed “cognitive and functional stability.” There are 32 patients in the trial; all are receiving the drug. (There is no placebo comparision.)
Alzheimer’s is difficult to treat in part because diagnosis is based on outward signs like memory loss. Those signs can come and go, or even go unnoticed for long periods. Researchers at the conference this week unveiled a new set of symptoms, known collectively as mild behavioral impairment, that doctors can use as a checklist for diagnosis. The symptoms encompass several types of behavior, such as apathy, anxiety, and impulse control.
Brain image courtesy of DJ via a Creative Commons license.
