MSD’s Alzheimer’s study could break new ground for treatment

pharmafile | November 3, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Alzheimer's, MSD, clinical trials 

MSD, known as Merck in North America, has published results of a Phase I trial of verubecestat. The drug is designed to inhibit the production of toxic amyloid beta peptide in the brain that leads to the neurodegeneration seen in the brains of Alzheimer’s patients.

The Phase I trial was primarily designed to access the safety profile of verubecestat. Previous attempts to treat patients in this manner have struggled due to strong, adverse side-effects that resulted in damage to vision or liver toxicity. In MSD’s trial, there were no study discontinuations due to adverse events and monitoring of vital signs displayed that there were no significant changes to vital functions as a result of administration of the drug.

Aside from the lack of worrying side-effects, the major positive for the results was the success in reduction in the levels of BACE1 activity, the toxic beta peptide. Patients were treated for one week, with once daily treatments of verubecestat, on varying strength doses. Patients received 12, 40 and 60mg doses, which saw the reduction of BACE1 activity by 57%, 79% and 84%, respectively.

Though in the early stages of clinical trial studies, this is encouraging news for MSD and for those suffering, or having the potential to suffer from, Alzheimer’s disease. MSD is currently going through the process of Phase II and III trials, with new results expected later next year. If the treatment is approved, it would be the first new treatment approved in more than a decade.

“The development of a potential disease modifying therapy for treatment of Alzheimer’s disease has long been a focus of biomedical research,” said Dr. Michael Egan, vice president, clinical development neurosciences, Merck Research Laboratories. “We believe this research has the potential to contribute important evidence regarding the amyloid hypothesis, a leading scientific theory for what causes Alzheimer’s disease, and we look forward to seeing the data from our ongoing Phase 3 clinical trials.”

Ben Hargreaves

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