” Furthermore, in the placebo-controlled clinical trial of neflamapimod in DLB patients, the beneficial impacts on cognition and motor function are consistent with neflamapimod treating the cholinergic deficit that underlies the medical discussion of DLB. Taken together, the findings suggest that neflamapimod appears to represent a scientific advancement towards treating degeneration of the basal forebrain cholinergic system, a long-standing objective of drug advancement for a series of neurodegenerative diseases.”
The basal forebrain is the main source of cholinergic neural stimulation in the brain, and its degeneration occurs in aging and neurodegenerative disease-related cognitive disorders, including Dementia with Lewy Bodies (DLB), the second most common type of neurodegenerative dementia. In DLB, dysfunction in the basal forebrain cholinergic neuron (BFCN) is an important chauffeur of illness expression and development.
” With this distinct mechanism that treats cholinergic neuronal degeneration, in vivo preclinically and clinically in DLB clients, we strongly think in neflamapimods capacity to play an essential function in the treatment of neurodegenerative diseases, especially in DLB where cholinergic dysfunction adds to both the cognitive deficits and gait dysfunction that together make this an especially devastating disease,” said John Alam, MD, clinical founder, and Chief Executive Officer of EIP Pharma.
” The cholinergic system has long been understood to be important in the pathogenesis of dementia, and neflamapimods profile is well matched to end up being a foundational treatment in a disease like DLB, where there are no authorized treatments. The data published today supply us self-confidence to advance neflamapimod into a confirmatory Phase 2b clinical trial in Dementia with Lewy Bodies.”
Recommendation: “Preclinical and Randomized Clinical Evaluation of the p38a Kinase Inhibitor Neflamapimod for Basal Forebrain Cholinergic Degeneration” by Jiang, Y., Alam, J.J., Gomperts S.N. et al., 21 September 2022, Nature Communications.DOI: 10.1038/ s41467-022-32944-3.
About Neflamapimod.
In pre-clinical studies, neflamapimod reverses synaptic dysfunction, consisting of within the part of the brain most impacted by Dementia with Lewy bodies (DLB)– the basal forebrain cholinergic system. Outcomes from the AscenD-LB Phase 2a clinical study demonstrated neflamapimod considerably improved cognition and function as measured by the gold standard dementia score test, the Clinical Dementia Rating Sum-of-Boxes (CDR-SB), and likewise revealed significant impact on motor function as determined by the Timed Up and Go test (TUG). The combined pre-clinical and medical data are consistent with neflamapimod dealing with the underlying illness procedure and having the possible to be the first disease-modifying treatment for DLB.
About EIP Pharma.
EIP Pharma, Inc. is a personal, clinical-stage biotechnology business advancing CNS-focused therapies to benefit patients with a series of crippling neurodegenerative diseases with considerable unmet patient requirement. The Company is focused on the capacity of neflamapimod, an investigational compound being evaluated for its prospective to deal with synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in Dementia with Lewy Bodies and particular other major neurological conditions.
A personal medical phase biopharmaceutical company focused on establishing investigative therapies for CNS illness with significant unmet patient requirement, EIP Pharma Inc., today (September 21) revealed the publication of a post in Nature Communications revealing translational arise from preclinical animal models to an exploratory, placebo-controlled clinical trial of neflamapimod in patients with mild to moderate Dementia with Lewy Bodies (DLB). The findings in “Preclinical and Randomized Clinical Evaluation of the p38a Kinase Inhibitor Neflamapimod for Basal Forebrain Cholinergic Degeneration” demonstrate that neflamapimods unique mechanism of action has the possible to improve cognitive and motor function in clients with neurodegenerative diseases affecting the basal forebrain cholinergic system, such as DLB.
The pre-clinical information were translated into the center in an exploratory Phase 2a medical trial in DLB clients in which neflamapimod was shown to be normally safe and well endured, and enhanced versus placebo the dementia, as assessed by the gold basic dementia score scale, and motor function. These combined pre-clinical and medical outcomes offer a foundation for a confirmatory, hypothesis-testing Phase 2b clinical research study examining neflamapimod for DLB.
Ralph A Nixon, MD, PhD, Director of the Center for Dementia Research at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg NY and senior author on the publication, commented, “We are pleased to report on the finding of a major translational step forward towards a therapy that treats cholinergic degeneration in the basal forebrain. We assumed that neflamapimod would attain this restorative objective because it hinders p38a kinase, an enzyme known to control activity of a central gamer in the pathogenic procedure underlying cholinergic degeneration, the endosome-associated protein Rab5. In an animal design, neflamapimod reduced Rab5 activity and reversed the neurodegenerative process in the basal forebrain.
Neflamapimod demonstrates that it reverses the neurodegenerative procedure in the basal forebrain cholinergic system in animal models.
Stage 2a data in Dementia with Lewy Bodies show positive effects of neflamapimod on medical endpoints associated with cholinergic neuronal function.
EIP Pharma prepares initiation of confirmatory Phase 2b clinical trial for DLB.
The pre-clinical data were equated into the center in an exploratory Phase 2a scientific trial in DLB clients in which neflamapimod was revealed to be generally safe and well tolerated, and improved versus placebo the dementia, as examined by the gold basic dementia score scale, and motor function. These combined pre-clinical and medical outcomes provide a structure for a confirmatory, hypothesis-testing Phase 2b clinical study assessing neflamapimod for DLB.
In pre-clinical research studies, neflamapimod reverses synaptic dysfunction, consisting of within the part of the brain most impacted by Dementia with Lewy bodies (DLB)– the basal forebrain cholinergic system. Outcomes from the AscenD-LB Phase 2a clinical study showed neflamapimod considerably enhanced cognition and function as determined by the gold standard dementia score test, the Clinical Dementia Rating Sum-of-Boxes (CDR-SB), and likewise showed significant effect on motor function as determined by the Timed Up and Go test (TUG). The combined pre-clinical and clinical information are consistent with neflamapimod dealing with the underlying disease procedure and having the possible to be the first disease-modifying treatment for DLB.
EIP Pharma publishes translational data of preclinical and phase 2a results for Neflamapimod in dementia with Lewy bodies.
J.J.A, A.G., and K.B. are workers of EIP Pharma, the sponsor of the clinical research study. S.N.G. has served on Advisory Boards of Jannsen, Acadia, and Sanofi, has actually received speaking with charges from EIP Pharma, and has actually received financing from the NIH, the DOD CDMRP, the Michael J. Fox Foundation, the FFFPRI, and the Lewy Body Dementia Association. J.E.H. reports invoice of personal charges in the past 2 years from Actinogen, AlzeCure, Aptinyx, Astra Zeneca, Athira Therapeutics, Axon Neuroscience, Axovant, Bial Biotech, Biogen Idec, BlackThornRx, Boehringer Ingelheim, Brands2life, Cerecin, Cognito, Cognition Therapeutics, Compass Pathways, Corlieve, Curasen, EIP Pharma, Eisai, G4X Discovery, GfHEU, Heptares, Ki Elements, Lundbeck, Lysosome Therapeutics, MyCognition, Neurocentria, Neurocog, Neurodyn Inc, Neurotrack, the NHS, Novartis, Novo Nordisk, Nutricia, Probiodrug, Prothena, Recognify, Regeneron, reMYND, Rodin Therapeutics, Samumed, Sanofi, Signant, Syndesi Therapeutics, Takeda, Vivoryon Therapeutics and Winterlight Labs.
