Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of two Phase II trials evaluating the efficacy of its glutamate modulator MK-1942 in patients with mild-to-moderate Alzheimer’s disease (AD) and treatment-resistant major depressive disorder (MDD). The decision comes after an unblinded data analysis indicated potential safety concerns.
Trial Termination and Safety Analysis
Despite the absence of serious adverse events (SAEs) during the trials, MSD made the decision to halt the studies following the identification of liver abnormalities in several participants. These findings raised concerns about a possible association between the daily administration of MK-1942 and liver toxicity, prompting the company to prioritize patient safety.
Implications for MSD and Future Research
The termination of the MK-1942 trials underscores MSD’s commitment to rigorous safety standards in clinical research. While this setback may impact the development timeline for new treatments in AD and MDD, it also serves as a reminder of the importance of thorough safety assessments in drug development.-Fineline Info & Tech