Merck MRK, known as MSD outside the United States and Canada, today
provided an update on the clinical program for preladenant, Merck's
investigational adenosine A2[A ]receptor antagonist for the treatment of
Parkinson's disease (PD). An initial review of data from three separate Phase
III trials did not provide evidence of efficacy for preladenant compared with
placebo.
Based on these results, Merck is taking steps to discontinue the extension
phases of these studies and no longer plans to pursue regulatory filings for
preladenant. The decision to discontinue these studies is not based on any
safety finding. The results of these studies will be presented at an upcoming
scientific meeting and will be submitted for publication in a peer-reviewed
journal.
“While these results are disappointing, this program is an important example
of Merck's continued commitment to pursue promising science with the goal of
bringing forward medicines that address important unmet medical needs,” said
David Michelson, M.D., vice president, clinical research, Neuroscience and
Ophthalmology at Merck Research Laboratories. “Parkinson's disease is very
complex, making it difficult to treat patients and develop novel therapeutic
approaches. We are committed to neuroscience research and will be conducting
further analyses of the data to inform the scientific community's efforts in
finding new approaches to treat this debilitating disease. We thank the
investigators and importantly the Parkinson's patients who participated in the
preladenant clinical program.”
The Phase III clinical program for preladenant included three randomized,
controlled clinical trials to evaluate safety and efficacy. Two of these
studies assessed preladenant when added to levodopa therapy in patients with
moderate-to-severe PD, and one assessed preladenant as monotherapy in early
PD. More information about the preladenant Phase III clinical trials is
available on www.clinicaltrials.gov.
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