EIP Pharma has published translational data of preclinical and phase 2a findings for Neflamapimod in dementia with Lewy bodies.
- Neflamapimod demonstrates that it reverses the neurodegenerative process in the basal forebrain cholinergic system in animal models.
- Phase 2a data in Dementia with Lewy Bodies show positive effects of neflamapimod on clinical endpoints associated with cholinergic neuronal function.
- EIP Pharma plans initiation of confirmatory Phase 2b clinical trial for DLB.
EIP Pharma Inc., a private clinical stage biopharmaceutical company focused on developing investigative treatments for CNS disorders with significant unmet patient demand, has published a paper in Nature Communications confirming the translational findings from preclinical animal models to an exploratory, placebo-controlled clinical trial of neflamapimod in mild to moderate Dementia with Lewy Bodies (DLB). The findings demonstrate that neflamapimod's unique mechanism of action has the potential to improve cognitive and motor
Neflamapimod, which has been approved by the FDA as a fast track therapy for DLB, is an oral, brain-penetrating small molecule that selectively targets and inhibits within the neuron the enzyme p38 MAP kinase alpha (p38a), which is known to regulate Rab5, a key protein implicated in the underlying disease process of neurodegeneration in the basal forebrain.
Ralph A Nixon, MD, PhD, Director of the Nathan S. Kline Institute for Psychiatric Research in Orangeburg NY, and the senior author of the paper, commented: “We are pleased to report on the discovery of a significant translational step forward toward a therapeutic treatment that treats cholinergic degeneration in the basal forebrain."
"The beneficial effects on cognition and motor function in the placebo-controlled clinical trial of neflamapimod in DLB patients are consistent with neflamapimod treating the cholinergic deficit that underlies the clinical presentation of DLB," according to the authors. "Neflamapimod appears to represent a scientific breakthrough towards treating the degeneration of the basal forebrain cholinergic system, a long-standing goal of drug development for a range of neurodegenerative diseases."
Degeneration of the basal forebrain is the primary source of cholinergic neural stimulation in the brain, including Dementia with Lewy Bodies (DLB), the second most common form of neurodegenerative dementia. In DLB, dyspnolysis of the basal forebrain cholinergic neuron (BFCN) is an important driver of disease expression and progression, and recent studies have shown that BFCN loss in Parkinson's Disease has the potential to alter the course of neurode
“We strongly believe that neflamapimod's potential to play an important role in the treatment of neurodegenerative disorders, particularly in DLB where cholinergic dysfunction contributes to both the cognitive deficits and gait dysfunction that make this a serious illness,” said John Alam, MD, scientific founder and Chief Executive Officer of EIP Pharma.
"The cholinergic system has been long known to be critical in the pathogenesis of dementia, and neflamapimod's profile is ideal to become a foundational therapy in a disease like DLB, where there are no approved therapies."
Jiang, Y., Alam, J.J., Gomperts S.N., and others, “Preclinical and Randomized Clinical Evaluation of the p38a Kinase Inhibitor Neflamapimod for Basal Forebrain Cholinergic Degeneration,” Nature Communications, 21 September 2022. DOI: 10.1038/s41467-022-32944-3.
Neflamapimod: What is it?
Neflamapimod is an investigational small molecule medication that inhibits the intra-cellular enzyme p38MAP kinase alpha (p38a), which is expressed in neurons under stress and disease. Neflamapimod also showed significant improvement in cognition, function, and executive function in patients with DLB.
EIP Pharma's About Us
EIP Pharma, Inc. is a private, clinical-stage biotechnology company advancing CNS-focused therapies to help patients with a wide spectrum of debilitating neurodegenerative illnesses with significant unmet patient need. The Company is investigating the potential of neflamapimod, an investigational compound being evaluated for its potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in Dementia with Lewy Bodies and other major neurological disorders.
J.J.A. has worked for and has held stock in EIP Pharma. J.J.A. has also served on the Advisory Boards of Jannsen, Acadia, and Sanofi, as well as received financial support from the National Institutes of Health, the Michael J. Fox Foundation, the FFFPRI, and the Lewy Body Dementia Association.