By Karen Pihl-Carey

Neurobiological Technologies Inc. (NTI) and collaborator Merz & Co. GmbH, of Frankfurt, Germany, said Memantine showed significant and positive results in a Phase III trial in patients with advanced Alzheimer's disease.

"This is one Phase III trial," said Lisa Carr, vice president of medical affairs for NTI, of Richmond, Calif. "We are currently looking for a marketing partner to help finance the second Phase III trial needed for submission [of a new drug application (NDA)]."

Carr said the company hopes to get the second Phase III under way sometime this year.

The first Phase III trial was a randomized, six-month-long, placebo-controlled, double-blind, multicenter study aimed at functional improvement of patients with moderate to severe Alzheimer's disease. It enrolled 252 patients in the U.S., and trial results confirm the findings of previous studies done in Europe and the U.S. The drug showed an excellent safety and tolerability profile, researchers said.

Barry Reisberg, of New York University Medical Centre, plans to disclose the Phase III data from the U.S. trial at the 7th Alzheimer's Annual Meeting in July. Results of two other placebo-controlled Phase III trials in mild to moderate vascular dementia conducted in Europe will be presented at the Springfield Meeting in Stockholm, Sweden, in April.

Carr said results from the dementia trials should support an NDA filing of Memantine for Alzheimer's in the U.S. Memantine is an orally available N-methyl-D-aspartate antagonist that appears to restore the function of impaired neurons.

Memantine also is being tested in other indications. NTI recently completed a placebo-controlled Phase IIb trial in diabetics with painful neuropathy. Data showed the dosing of 40 mg resulted in a statistically significant reduction of nighttime pain intensity compared with placebo.

"That was positive," Carr said, "and I think we hope to go on for one more pivotal trial in order to finish."

Complete results from the Phase IIb trial will be presented at the 52nd Annual Meeting of the American Academy of Neurology in San Diego.

In November 1998, data from a Phase III trial of Memantine showed statistically significant improvement in functional independence in patients with severe dementia. (See BioWorld Today, Nov. 18, 1998, p. 1.)