Shares of Transition Therapeutics (TTHI) tumbled 73% today after reporting that it failed its phase 2/3 in patients with Alzheimer's disease. More specifically the company produced its clinical drug candidate known as ELND005 to reduce agitation and aggression in patients with Alzheimer's. This phase 2/3 trial enrolled approximately 350 patients Alzheimer's patients who were randomized into two different dosing groups.
One set of 175 patients took ELND005 and the other set of patients took a placebo compound. The primary endpoint of the study tested for the change in baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) scale. The key point to know about this scale is that it is what investigators use to determine the change in baseline in measuring agitation and aggression in Alzheimer's patients.
The company reported that the trial showed the drug was safe and tolerable over the 12-week treatment period. The problem was that the ELND005 drug compound failed to meet the primary endpoint of the study - in fact the placebo saw a greater reduction in agitation and aggression in these patients. The company will now have to obtain the rest of the data and will have a clinical advisory committee that will determine if ELND005 has any future in patients with Alzheimer's.
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