neflamapimod (VX-745) / CervoMed - LARVOL DELTA

Neuronal p38 MAPK Signaling Contributes to Cisplatin-Induced Peripheral Neuropathy. (PubMed, Antioxidants (Basel)) - "This study investigates the role of p38 mitogen-activated protein kinase (MAPK) activation in dorsal root ganglion (DRG) neurons in the development and progression of chemotherapy-induced peripheral neuropathy (CIPN). This study identifies p38 MAPK activation as a critical driver of CIPN and highlights its potential as a therapeutic target for CIPN. Targeting p38 MAPK activation with neflamapimod offers a promising strategy to mitigate neurotoxicity and hyperalgesia without exacerbating cancer progression, positioning it as a novel intervention for CIPN."

Journal • Breast Cancer • Metabolic Disorders • Musculoskeletal Diseases • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • CASP3

EFFICACY AND SAFETY RESULTS OF THE REWIND-LB PHASE 2B CLINICAL TRIAL OF NEFLAMAPIMOD IN DEMENTIA WITH LEWY BODIES (DLB) (ADPD 2025) - P2 | "Aims To report the Results of the RewinD-LB phase-2b clinical study (NCT05869669) of neflamapimod (oral p38α kinase inhibitor targeting cholinergic degeneration) in patients with DLB. prevalence of core clinical features: fluctuations=73%, visual hallucinations=57%, REM sleep disorder=78%, parkinsonism=87%; 75% were receiving AChEI therapy (of which 15% were also receiving memantine) and 3% were receiving memantine without AChEI. Conclusions All main major clinical, EEG, plasma biomarker and MRI Results , as well the safety findings, from the 16-week placebo-controlled portion of the study will be presented."

Clinical • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder • GFAP • p-tau181

CervoMed Announces Oral Presentation at 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AP/PD) (GlobeNewswire) - "CervoMed Inc...today announced it will deliver an oral presentation at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AP/PD), being held on April 1-5, 2025 in in Vienna, Austria. The Company will be presenting detailed analyses from the Extension Phase of the RewinD-LB Phase 2b study of neflamapimod in dementia with Lewy bodies (DLB)."

P2b data • Dementia

CervoMed Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Updates (GlobeNewswire) - "The 16-week results from the extension phase of the Phase 2b RewinD-LB trial have been accepted as an oral presentation at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AD/PD) in Vienna, Austria, April 1-5, 2025....The Company expects to report 32-week results from the extension phase of the RewinD-LB trial in the second half of 2025. Initial safety, biomarker and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB being treated with a twice daily regimen (80mg BID) of neflamapimod is expected to be available in the fourth quarter of 2025....CervoMed plans to initiate a Phase 2a trial evaluating neflamapimod in the nonfluent/agrammatic variant of primary progressive aphasia – a subtype of FTD – in mid-2025."

New P2a trial • P2b data • Dementia • Lewy Body Disease

EFFICACY AND SAFETY RESULTS OF THE REWIND-LB PHASE 2B CLINICAL TRIAL OF NEFLAMAPIMOD IN DEMENTIA WITH LEWY BODIES (ADPD 2025) - P2 | "Aims To report the results of the RewinD-LB phase-2b clinical study (NCT05869669) of neflamapimod (oral p38α kinase inhibitor targeting cholinergic degeneration) in patients with DLB. prevalence of core clinical features: fluctuations=73%, visual hallucinations=57%, REM sleep disorder=78%, parkinsonism=87%; 75% were receiving AChEI therapy (of which 15% were also receiving memantine) and 3% were receiving memantine without AChEI. Conclusions All main major clinical, EEG, plasma biomarker and MRI results, as well the safety findings, from the 16-week placebo-controlled portion of the study will be presented."

Clinical • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder • GFAP • p-tau181

CervoMed Announces Positive Results from the Extension Phase of its Phase 2b Clinical Study of Neflamapimod in Patients with Dementia with Lewy Bodies (GlobeNewswire) - P2b | N=159 | RewinD-LB (NCT05869669) | Sponsor: EIP Pharma Inc | "From the end of the Initial phase of the study (i.e. Day 1 of the Extension) through to Week 16 of the Extension, the change in CDR-SB was lower in the New Capsule group compared to the Old Capsule group (difference=-0.73, 95% CI: -1.14, -0.32; p<0.001)....On CGIC, which was administered at Week 8 of the Extension, administration of the New Capsules led to an improved score (4.02 vs. 4.46 with Old Capsules, p=0.035), indicating less worsening with New Capsule administration. A greater magnitude difference was also observed in participants with screening plasma ptau181 < 2.2 pg/mL (3.90 with New Capsules vs. 4.45 with Old Capsules, p=0.011)....'We are excited to complete the full 32-weeks of the extension phase of the study and look forward to engaging with regulatory authorities to discuss finalizing our Phase 3 plans after these additional data are available later this year'."

P2b data • Dementia • Lewy Body Disease

Efficacy of Pharmacological Interventions in Lewy Body Dementia: An Updated Systematic Review and Network Meta-Analysis (AAN 2025) - "Donepezil 5 mg and 10 mg significantly improved MMSE scores in LBD patients. Neflamapimod (BD) showed non-significant improvement on the NPI scale, while Bosutinib 100 mg was linked to higher rates of SAEs and mortality."

Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Psychiatry

Efficacy and Safety of the RewinD-LB Phase 2b Clinical Trial of Neflamapimod in Dementia With Lewy Bodies (DLB) (AAN 2025) - P2 | "Objective:To obtain definitive clinical proof-of-concept for, i.e. demonstrate the efficacy of, the oral p38α kinase inhibitor neflamapimod as a treatment for dementia with Lewy bodies (DLB).Background:The RewinD-LB phase 2b clinical study (NCT05869669) of neflamapimod, targeting cholinergic degeneration, was initiated to confirm phase 2a results, in which neflamapimod demonstrated positive effects in mild-to-moderate DLB on multiple clinical endpoints measuring cognition and/or function, most prominently in patients without elevation in plasma levels of the neurodegeneration biomarker ptau181.Design/16-week, double-blind, placebo-controlled clinical trial, with 32-week open-label-extension. Analysis of all clinical, EEG, plasma biomarker and MRI endpoints as well safety, from the 16-week placebo-controlled portion of the study will be completed in the first quarter of 2025, and presented at the meeting."

Clinical • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder • GFAP • p-tau181

RewinD-LB - Clinical Study of Neflamapimod in Patients with Dementia with Lewy Bodies (clinicaltrials.gov) - P2 | N=159 | Active, not recruiting | Sponsor: EIP Pharma Inc | Trial completion date: Mar 2025 ➔ Jun 2025

Trial completion date • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

An Open-Label Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: EIP Pharma Inc

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Provides Update on Neflamapimod DLB Program as Part of Presentation at the 8th International Lewy Body Dementia Conference (GlobeNewswire) - P2b | N=160 | RewinD-LB (NCT05869669) | Sponsor: EIP Pharma Inc | "No discernible differences between neflamapimod 40mg dosed three times daily (TID) and placebo treatment groups during the 16-week double-blind phase of the clinical study. Measured trough plasma drug concentrations during the double-blind phase were, on average, similar to those seen with 40mg twice-daily (BID) dosing in a previous study in Alzheimer’s Disease, a potential explanation for the current results. Retrospective analysis of the capsules suggests the lower–than-expected bioavailability may be related primarily to the age of the drug batch utilized during the double-blind phase of the study...Topline data from the first 16 weeks of the OLE phase of the RewinD-LB trial are expected in 1Q 2025."

P2b data • Dementia • Lewy Body Disease

CervoMed to Present at the 8th International Lewy Body Dementia Conference (GlobeNewswire) - "CervoMed Inc...today announced that topline results from the Phase 2b RewinD-LB study will be presented at the 8th International Lewy Body Dementia Conference (ILBDC), being held in Amsterdam, on January 31, 2025."

P2b data • CNS Disorders • Lewy Body Disease

Drug Development. (PubMed, Alzheimers Dement) - "Currently, Lewy body dementias are excluded from the appropriate use recommendations for Aducanumab and not mentioned in the Lecanemab appropriate use recommendations...In a recent Phase II study of neflamapimod, individuals with DLB and AD biomarkers were also less responsive to the experimental therapy. This warrants consideration of AD biomarkers in clinical trial design which will be discussed during the session. Finally, we will comment on how the presence of copathology, specifically LBD, can also affect current AD-specific clinical trials."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Drug Development. (PubMed, Alzheimers Dement) - P2 | "The beneficial effects on GFAP further support that neflamapimod is clinically efficacious in patients with DLB. The results also demonstrate the potential of GFAP as biomarker to assess treatment effects in DLB, though treatment effects may be masked in patients with AD co-pathology."

Journal • Alzheimer's Disease • CNS Disorders • FAP • GFAP • NEFL • Plasma NfL • p-tau181

CervoMed Announces Topline Data from RewinD-LB Phase 2b Clinical Trial in Patients with Dementia with Lewy Bodies (GlobeNewswire) - P2b | N=160 | RewinD-LB (NCT05869669) | Sponsor: EIP Pharma Inc | "CervoMed Inc...today announced topline data from the RewinD-LB Phase 2b clinical trial evaluating neflamapimod for the treatment of patients with dementia with Lewy bodies (DLB). The trial did not meet statistical significance thresholds for its primary endpoint of change in the Clinical Dementia Rating Sum of Boxes (CDR-SB) or any of its key secondary endpoints...Initial analysis shows that target plasma drug concentrations were not achieved during the double-blind phase of the trial, which may have adversely impacted trial results...The full data set from the double-blind phase of the RewinD-LB trial is expected to be available to the Company in January 2025 and the data from the first 16 weeks of the open label extension portion of the trial are expected to be available in the late second quarter of 2025."

P2b data • CNS Disorders • Lewy Body Disease

CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia (GlobeNewswire) - "On track to report topline data from the RewinD-LB Phase 2b clinical trial in early-stage dementia with Lewy bodies (DLB) in December 2024...CervoMed Inc...announced that its oral investigational drug neflamapimod has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of frontotemporal dementia (FTD)....'while continuing to prepare to advance neflamapimod into a Phase 3 trial in DLB in mid-2025.'"

Orphan drug • P2b data • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Announces Key Takeaways from Oral Presentations at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD) (GlobeNewswire) - P2b | N=160 | RewinD-LB (NCT05869669) | Sponsor: EIP Pharma Inc | "CervoMed Inc...today announced key takeaways from two oral presentations characterizing the potential of neflamapimod as a treatment for patients with dementia with Lewy bodies (DLB) that were presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD) on November 1, 2024....Key takeaways from the presentations: We have demonstrated a treatment effect on a robust biomarker of neurogenerative disease activity in DLB....We are targeting a patient population that is most likely to respond to neflamapimod in the RewinD-LB trial....By exclusively enrolling patients without biomarker evidence of tau pathology the sample size of RewinD-LB provides high statistical power to detect a statistically significant and clinically meaningful difference between neflamapimod and placebo."

Biomarker • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Cold Storage-Mediated Activation of P38MAPK-MK2 Axis Induces Kidney Injury after Transplantation (KIDNEY WEEK 2024) - "Our data indicate that the P38MAPK is a contributor of CS-mediated proteasome dysfunction and renal injury. Similarly, P38MAPK-MK2 axis may promote inflammation in renal cells during CS+Tx and this pathway may serve as a new therapeutic target to improve the outcomes of kidney transplantation and potential clinical applications during organ transplant."

Inflammation • Renal Disease • Solid Organ Transplantation • Transplantation

Plasma biomarker data indicates clinical activity of neflamapimod in dementia with Lewy bodies (DLB) is mediated through effects on the basal forebrain cholinergic system (CTAD 2024) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Announces Last Patient Last Visit in Phase 2b RewinD-LB Trial of Neflamapimod for the Treatment of Early-Stage Dementia with Lewy Bodies (DLB) (GlobeNewswire) - "CervoMed Inc...today announced the Last Patient Last Visit in RewinD-LB, a Phase 2b clinical trial evaluating neflamapimod in patients with early-stage dementia with Lewy bodies (DLB)...'We are also encouraged by the fact that 96% of the patients enrolled into the study completed the 16-week double-blind placebo-controlled portion of the study, of which 98% continued into the open label extension.'"

Trial status • CNS Disorders • Dementia • Lewy Body Disease

CervoMed to Deliver Late-Breaking Oral Presentations at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD) (GlobeNewswire) - "Plasma biomarker data from AscenD-LB Phase 2a study and baseline data from the RewinD-LB Phase 2b study to be featured in late-breaking oral presentations at CTAD."

Biomarker • Late-breaking abstract • P2a data • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

p38α Mitogen-Activated Protein Kinase-An Emerging Drug Target for the Treatment of Alzheimer's Disease. (PubMed, Molecules) - "The increased activation of the p38α MAPK pathway, observed in AD, has been for a long time associated not only with the maintenance of excessive inflammatory process but is also linked with pathophysiological hallmarks of this disease, and therefore is currently considered an attractive drug target for novel AD therapeutics. This review aims to summarize the current state of knowledge about the involvement of p38α MAPK in different aspects of AD pathophysiology and also provides insight into the possible therapeutic effects of novel p38α MAPK inhibitors, which are currently studied as potential drug candidates for AD treatment."

Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation

Screening outcomes and baseline disease characteristics in the RewinD-LB phase 2b clinical trial of neflamapimod in patients with early dementia with Lewy bodies (DLB) (CTAD 2024) - No abstract available

Clinical • P2b data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Featured in Fortune for Advances in the Treatment of Dementia with Lewy Bodies (GlobeNewswire) - "CervoMed Inc...today announced its recent feature in Fortune magazine. In the article...CervoMed was recognized for its pioneering work in developing neflamapimod, a potentially transformative treatment for patients suffering from dementia with Lewy bodies (DLB)...'we look forward to sharing the topline results from our Phase 2b RewinD-LB study in December 2024.'"

Clinical • P2b data • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Announces Presentation at AAIC 2024 on Plasma Biomarker Data That Are Consistent with Neflamapimod Impacting the Underlying Disease Process in Patients with Dementia with Lewy bodies (DLB) (GlobeNewswire) - P2a | N=91 | AscenD-LB (NCT04001517) | Sponsor: EIP Pharma Inc | "Baseline data from the AscenD-LB Phase 2a trial in DLB demonstrated that plasma glial fibrillary acidic protein (GFAP) was highly correlated to scores on the CDR-SB; plasma GFAP shown to increase with neurodegenerative progression in DLB; AscenD-LB Phase 2a results demonstrated neflamapimod treatment led to significant reduction compared to placebo in plasma GFAP levels in patients with DLB and the effects of neflamapimod on plasma GFAP were associated with improvement in CDR-SB....CervoMed Inc...today announced that plasma biomarker data from the AscenD-LB Phase 2a trial of neflamapimod in patients with dementia with Lewy bodies (DLB), was featured in a poster presentation at the Alzheimer's Association International Conference (AAIC), being held in Philadelphia from July 28-August 1, 2024."

Biomarker • P2a data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease