This week the fight against Alzheimer’s disease received another setback when Merck halted the Phase 2/3 trial for their beta-site amyloid precursor protein cleaving enzyme (BACE) inhibitor, verubecestat, in patients with mild-to-moderate Alzheimer’s disease. The decision to halt the trial was based on the results of an interim safety analysis which suggested there was virtually no chance of finding a positive clinical effect.
The amyloid hypothesis is one of the leading hypotheses behind the pathogenesis of Alzheimer’s disease. It is believed that a buildup of amyloid plaques may be responsible for disease onset, and BACE inhibitors, such as verubecestat, would help prevent the amyloid accumulation. These interim results further bring into question the therapeutic impact of the amyloid hypothesis.
The Alzheimer’s market has been a tough one to crack into, with many drugs failing in late stage-development. However, all hope is not lost for verubecestat and the amyloid hypothesis as Merck will continue to investigate the BACE inhibitor in another Phase III trial looking at patients with earlier forms of the disease.