Introduction:
ALZ-801 is a novel, orally available small molecule prodrug of tramiprosate with improved pharmaceutical properties. Tramiprosate was advanced to a ~2,000 patient Phase 3 program which completed in 2007, and was deemed inconclusive by the FDA. Subsequent post-hoc analyses of ApoE4 positive patients (n=599) showed that tramiprosate produced a significant and clinically meaningful improvement in cognition and function at 6, 12 and 18 months on top of standard of care therapy. ALZ-801 has been optimized for improved absorption, improved GI tolerability and improved PK properties (i.e. longer t1/2 and decreased PK variability). Oral ALZ-801 increases the plasma and brain exposure of tramiprosate in animals 2-fold over tramiprosate administered at equimolar doses.
