EIP Pharma Initiates New Study with Neflamapimod for the Treatment of Cognitive Deficits in Patients with Dementia with Lewy Bodies
New clinical trial marks third study underway with neflamapimod in neurodegenerative disease
CAMBRIDGE, Mass., July 12, 2019 /PRNewswire/ -- EIP Pharma, Inc., a CNS-focused therapeutics company, today announced the initiation of a new Phase 2 proof-of-concept study evaluating neflamapimod as a treatment for the cognitive dysfunction associated with dementia with Lewy bodies (DLB). The primary objective of the study is to determine whether neflamapimod, a brain-penetrant, oral small molecule that inhibits the enzyme p38 alpha, can reverse the hippocampal synaptic dysfunction associated with DLB.
"Dementia with Lewy bodies is the second most common dementia after Alzheimer's disease and yet there are no approved therapies to address this progressive disorder. We believe that by targeting synaptic dysfunction, neflamapimod may improve the cognitive impairment associated with DLB with the potential to change the course of a patient's disease," said John Alam, MD, founder and CEO of EIP Pharma. "This trial, along with our two other ongoing trials in Huntington's and Alzheimer's disease will provide us with a stronger understanding of the potential of neflamapimod to reverse synaptic dysfunction in a broad range of neurodegenerative diseases."
This evaluation of neflamapimod is based on its mechanism of action, targeting inhibition of the enzyme p38 MAP kinase alpha (p38α), which has been recognized as a mechanism to reverse synaptic dysfunction in a range of CNS disorders. DLB has an underlying pathogenesis overlapping Alzheimer's disease (AD), sharing common neuroinflammatory mechanisms and is genetically correlated to both AD and Parkinson's disease (PD). Neurotoxicity of alpha-synuclein, the primary constituent of Lewy bodies, is common to both DLB and PD and p38 activation has been linked to neurotoxicity of alpha-synuclein.
This Phase 2 proof-of-concept study is a double-blind, placebo-controlled, 16-week treatment study of neflamapimod in Stage 1 DLB. The primary objective is to determine whether neflamapimod can improve synaptic dysfunction in patients with DLB, as assessed by a neuropsychological test battery evaluating attention, executive function and visuospatial deficits. The study will also assess changes on EEG and several other DLB symptoms via standard scales and will be stratified based on a screening International Shopping List score. The study will be conducted at several sites in the U.S. and Netherlands and will evaluate approximately 80 patients. Data from the study are expected in the second half of 2020.
Neflamapimod is a brain-penetrant, oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38α). P38α, which is expressed in neurons under conditions of stress and disease, plays a major role in inflammation-induced synaptic toxicity, leading to impairment of synaptic function. Synaptic dysfunction is known to be a major drive of the deficits in cognitive function that are defining characteristics of many CNS diseases. Neflamapimod is currently being studied in a Phase 2b trial for early Alzheimer's disease and in a Phase 2 trial in patients with Huntington's disease who have evidence of cognitive dysfunction.
About Dementia with Lewy Bodies
Dementia with Lewy bodies (DLB) is a serious disease representing approximately 20 percent of the dementia population, with an estimated 1.4 million affected individuals in the US. DLB is characterized by progressive dementia and fluctuating cognition (deficits in memory and attention), sleep disturbances, visual hallucination and parkinsonism (tremor and gait disturbances). Although it is a separate disease, it can be difficult to differentiate from the related dementias of AD and Parkinson's disease. The prognosis for DLB is even more severe than that of AD with an average time from diagnosis to death of just four to seven years.
About EIP Pharma Inc
EIP Pharma, Inc. is a private, Cambridge, MA-based company advancing CNS-focused therapeutics to benefit patients with neurodegenerative diseases.
For more information, please visit www.eippharma.com.
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