20 June 2007. Privately owned CoMentis Inc. announced yesterday that it had received U.S. Food and Drug Administration clearance to begin a phase 1 trial of its β-secretase (BACE) inhibitor CTS-21166, which it hopes to develop for the treatment of Alzheimer disease. The trial is designed to study the safety, tolerability, and pharmacokinetics of the drug in 48 human subjects. According to the company’s press release, phase 2 studies may begin in AD patients as early as 2008.
BACE is thought to play a key role in AD by performing the first of two cuts needed to extricate amyloid-β from its precursor protein. The protease has become a prime drug target for AD and several pharmaceutical and biotech companies are actively pursuing development of BACE inhibitors. BACE was recently discovered to play a major role in neurodevelopment by promoting myelination of motor neurons. For more of the latest news on BACE, see Gabrielle Strobel’s comprehensive roundup of BACE presentations at the International Conference on Alzheimer Disease last July in Madrid, Spain.—Tom Fagan.