Merck & Co. (NYSE: MRK) saw its shares slip on Wednesday after the firm reported that it will be halting its mid-to-late-stage clinical trial for the treatment of Alzheimer’s disease. Unfortunately, this is not the first time this year that Merck has received bad news for its Alzheimer’s study. The company is stopping the Phase 2/3 study following the recommendation of the external Data Monitoring Committee (eDMC).
In a recent safety analysis, the eDMC assessed the benefit/risk of the EPOCH study, also known as protocol 017, for Alzheimer’s and determined that there was “virtually no chance of finding a positive clinical effect.” The committee further noted that safety signals observed in the study “are not sufficient to warrant stopping study 017,” and recommended that protocol 019, also known as APECS, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged.
The results from protocol 019 are expected in February 2019. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting.
The efficacy and safety of verubecestat was being evaluated in two pivotal Phase 3 clinical trials: Protocol 017, or EPOCH, in mild-to-moderate Alzheimer’s, and Protocol 019, or APECS, in prodromal Alzheimer’s. There is a slight difference in each. Patients with mild to moderate Alzheimer’s exhibit detectable and worsening impairment of cognitive and functional abilities. Patients with prodromal Alzheimer’s have objective memory problems but relatively normal functioning in activities of daily living.
Dr. Roger M. Perlmutter, president of Merck Research Laboratories, commented:
Alzheimer’s disease is one of the most pressing and daunting medical issues of our time, with inherent, substantial challenges to developing an effective disease-modifying therapy for people with mild-to-moderate disease. Studies such as EPOCH are critical, and we are indebted to the patients in this study and their caregivers. While we are disappointed that a benefit was not observed in this study, our work continues with APECS, which is studying verubecestat in people with less advanced disease.
Shares of Merck were trading down 0.5% at $65.30 on Wednesday, with a consensus analyst price target of $68.55 and a 52-week trading range of $49.63 to $65.87.