February 8, 2023
The U.S. National Institute on Aging (NIA), part of the National Institutes of Health (NIH), has awarded $21M for a clinical trial in people with dementia with Lewy bodies (DLB). EIP Pharma’s investigational drug neflamapimod is designed to target a protein in the brain that is activated by stressors, including brain changes associated with the development of dementia.
Earlier studies of this drug indicate that it affects a part of the brain implicated in DLB. Furthermore, a previous clinical trial suggested that the drug may slow decline in mobility and cognitive function in people with DLB. In 2019, neflamapimod received Fast Track designation from the U.S. FDA for the treatment of DLB, and EIP Pharma began the AscenD-LB phase 2a clinical trial of the drug in people with mild-to-moderate DLB. Positive results from the study were announced in 2020 and published after peer review in 2022.
Dr. James Galvin, member of the LBDA Board of Directors and Scientific Advisory Board, and co-principal investigator for the study, commented “There are no approved therapies for the treatment of the disease and standard of care does not alter the inevitable progression of the disease. Patients suffer from deficits in attention, cognition and gait function and these issues create an inordinate burden of care not only for the patients but also for the caregivers. The NIA grant will fund a study that will be instrumental in fully understanding whether neflamapimod has the potential to become an important treatment for patients with DLB”.
EIP Pharma CEO, John Alam, MD, stated “We are grateful to the NIA that, based on the peer-review scientific evaluation of the project, they have awarded a grant that will fund the costs of a proof a concept trial for neflamapimod in patients with DLB. The outcome of this phase 2b study could allow us to confirm the positive findings from our phase 2a study and definitively demonstrate the potential for neflamapimod to treat patients suffering from the second most common dementia, DLB.” Alam also said EIP looks forward to the phase 2b study commencing “within the next few months.”
As the recognized leader in Lewy body dementias, the LBDA will support this trial through outreach, education and engagement of through our Research Centers of Excellence.
You can find information about ongoing clinical trials for people with Lewy body dementia by visiting the LBDA’s clinical studies webpage.