Phase 3 trial proves unsuccessful
NEW YORK -- Dow Jones Newswires reported Forest Laboratories Inc. said its neramexane failed to produce statistically significant improvements in a Phase 3 trial studying the drug as a treatment for Alzheimer's disease.
In a press release, the drug maker said the six-month double-blind study of 415 outpatients weighed the safety and efficacy of neramexane combined with three widely-prescribed acetylcholinesterase inhibitors against results from treatment using the inhibitors alone.
Preliminary analysis showed patients taking neramexane didn’t see statistically different results to those on combined doses.
A particular measure of cognition and another of functionality were the primary endpoints of the study. The secondary endpoint - the clinician's interview-based impression of change plus caregiver input - failed to show statistical significance. Forest will analyze the data further in the coming months.
Neramexane is designed to block selectively the effects associated with abnormal transmission of glutamate, which has a role in the neural pathways associated with learning and memory, while allowing for normal cell function. The study didn’t identify any safety issues.
Forest is enrolling moderate-to-severe Alzheimer's patients in a second Phase 2/3 study comparing neramexane as a monotherapy with placebo treatment. It plans to continue developing the compound, collaborating with the drug's licensor, German specialty pharmaceutical maker Merz GmbH.