BioWorld International Correspondent
NeuroSearch A/S and Boehringer Ingelheim GmbH are moving their candidate central nervous system drug, NS2330, into a Phase IIb trial that will involve some 400 Alzheimer's patients in 50 centers in the U.S. and Canada.
The study is expected to take a year to complete. If successful, Ballerup, Denmark-based NeuroSearch plans to commence Phase III trials in 2004 and hopes to be ready to file an NDA by 2006.
NS2330 also is in development for Parkinson's disease, for which it is due to enter a full Phase II trial in the first quarter of next year. NeuroSearch entered a US$80 million development pact with Ingelheim, Germany-based Boehringer Ingelheim earlier this year in both indications. (See BioWorld International, Feb. 13, 2002.)
The concept underlying the use of NS2330 in Alzheimer's is a new one, NeuroSearch President and CEO J rgen Buus Lassen told BioWorld International. The compound, the structure of which has not yet been disclosed, influences the levels of three key neurotransmitters - noradrenaline, which is important in attention-related functioning; acetylcholine, which plays a role in memory; and dopamine, which is involved in both functions. It works by blocking the reuptake of noradrenaline and dopamine and by boosting the release of acetylcholine. The latter effect appears to be localized to the hippocampus and the prefrontal cortex regions of the brain, the functioning of which is impaired in Alzheimer's disease patients.
Lassen said studies in healthy volunteers who received either 0.5 mg/day or 0.25 mg/day over a 10-day period indicated that NS2330 blocks dopamine reuptake in the brain. "This should be sufficient to really enhance the function of the nerve cells," he said. In the upcoming trial, the participants assigned to the dosage groups will receive either 0.25 mg, 0.5 mg or 1 mg of NS2330 per day. "We are quite sure that they are biologically active. They showed efficacy and tolerability in the earlier studies," he said.
The news pushed the company's share price up DKK2 to DKK57 on the Copenhagen Stock Exchange Monday.