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. Alzheimer’s Failures. Sadly, 2018 marked yet another bad year for Alzheimer’s disease drug development. Here are just some of the year’s biggest failures in this area. On January 25, 2018, Takeda Pharmaceutical and its development partner Zinfandel Pharmaceuticals gave up on their five-year Phase III TOMORROW trial after an interim analysis of pioglitazone in mild cognitive impairment due to Alzheimer’s disease. The safety was generally considered fine, but there was inadequate treatment effect.
On February 9, 2018, Boehringer Ingelheim indicated it was abandoning its Phase II compound BI 409306 after it failed to meet its endpoints. The drug, a PDE9 inhibitor, being used to treat patients with cognitive impairment and memory dysfunction in schizophrenia and Alzheimer’s, failed to show superiority over placebo in cognition in two separate clinical trials. On February 14, Merck & Company said it was halting protocol 019, its APECS Phase III clinical trial of verubecestat (MK-8931) in Alzheimer’s. An external Data Monitoring Committee (eDMC) had recommended ending it after an interim safety analysis, saying the likelihood of benefits didn’t outweigh the risks.
On April 10, vTv Therapeutics announced its azeliragon failed to meet either co-primary efficacy endpoint in its Phase III STEADFAST clinical trial in patients with mild Alzheimer’s disease. On May 18, Johnson & Johnson’s Janssen division halted its clinical trials of atabacestat, a BACE inhibitor, for Alzheimer’s disease. It was ending the program over safety issues, rather than efficacy. And on September 18, Allergan and Sosei voluntarily suspended clinical trials of HTL0018318 in Alzheimer’s and other types of dementia because of safety issues.