neflamapimod (VX-745) / CervoMed - LARVOL DELTA

Bioinformatics and Machine-Learning Identification of Pulmonary Hypertension Biomarkers and Candidate Therapeutic Compounds. (PubMed, J Vis Exp) - "MAPK14/p38α, its established pharmacological target, was included as a positive-reference docking protein, whereas docking against the five biomarker-associated proteins was treated as exploratory. These findings support the five genes as candidate PH biomarkers and VX-745 as a computational drug-repositioning hypothesis requiring experimental validation."

Biomarker • Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CXCL10 • IFIH1 • MAPK14 • MX1 • TLR7

P38α deficiency alleviates myocardial ischemia/reperfusion injury by stabilizing c‑Myc to inhibit ferroptosis. (PubMed, Basic Res Cardiol) - "Pretreatment with the p38α inhibitor VX-745 recapitulated the cardioprotective effects by restoring the p38α/c-Myc/NCOA4 axis in vivo. Collectively, our findings identify the p38α/c-Myc/NCOA4 signaling axis as a regulatory cascade governing myocardial I/R-induced ferroptosis. These findings nominate the p38α/c-Myc/NCOA4 axis as a potential therapeutic target in myocardial I/R injury."

Journal • Cardiovascular • Coronary Artery Disease • Heart Failure • Hematological Disorders • Myocardial Infarction • Myocardial Ischemia • Reperfusion Injury • Targeted Protein Degradation • MAPK14 • MYC • NCOA4

Phase 2a clinical trial of the oral p38α kinase inhibitor neflamapimod in patients with non-fluent variant primary progressive aphasia (CTAD 2026) - No abstract available

Clinical • P2a data

FTD: CervoMed will present 12-week biomarker data from the first eight participants in its ongoing Phase 2a trial in patients with nfvPPA at ISFTD, taking place October 8-11, 2026, in Philadelphia, Pennsylvania. (The Manila Times) - "Full 12-week and initial, 24-week biomarker data from the trial will be presented at the 19th CTAD conference, taking place November 16-19, 2026, in Boston, Massachusetts. The Company also expects to report initial topline clinical data, as well as additional biomarker data, in the first quarter of 2027."

Biomarker • P2a data • Dementia • Frontotemporal Lobar Degeneration

ALS: CervoMed expects to dose the first patient in its EXPERTS-ALS trial evaluating neflamapimod for the treatment of amyotrophic lateral sclerosis (ALS) by the end of 2026. (The Manila Times)

New P2a trial • Amyotrophic Lateral Sclerosis

Anticipated Milestones (The Manila Times) - "DLB: CervoMed will continue to advance its strategic objective to establish a partnership to advance neflamapimod into a pivotal, Phase 3 clinical trial in patients with DLB."

New P3 trial • Dementia • Lewy Body Disease

CervoMed Announces Neflamapimod Awarded Innovation Passport Designation Under the UK Innovative Licensing and Access Pathway (ILAP) for Treatment of Dementia with Lewy Bodies (DLB) (CervoMed Press Release) - "The Innovation Passport designation provides access to a single integrated platform for sustained collaboration between biopharmaceutical companies and the ILAP Partners: the MHRA, NHS, the HTA bodies – the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Therapeutics and Toxicology Centre (AWTTC), and the Department of Health Northern Ireland. This includes priority access to services such as clinical trials support and NHS engagement, to help speed up access for patients where current treatment options are limited or non-existent."

Commercial • Dementia • Lewy Body Disease

CervoMed to Participate in Fireside Chat to Highlight Recent Progress in the Neflamapimod Clinical Development Program at the Canaccord Genuity 46th Annual Growth Conference (The Manila Times) - "...Canaccord Genuity 46th Annual Growth Conference, being held in Boston, MA, on Tuesday, August 11, 2026."

Clinical • Dementia • Lewy Body Disease

Design of a phase 3 clinical trial of the oral p38α kinase inhibitor neflamapimod in patients with dementia with Lewy bodies (DLB) (CTAD 2026) - No abstract available

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

New PK-PD Analysis and Phase 2 Study Results for Neflamapimod 80 mg BID in DLB Strengthen Understanding of Dosing (CervoMed Press Release) - "A new analysis showed that a consistent pharmacokinetic-pharmacodynamic relationship has been observed across nonclinical and clinical studies of neflamapimod, with a plasma trough drug concentration (Ctrough) threshold (~4 ng/mL) associated with biomarker and clinical improvements. The 4 ng/mL plasma threshold exceeds the in vitro concentration necessary to produce neflamapimod's primary pharmacologic effect, inhibition of interleukin-1β neurotoxic signaling...Based on the above findings, the dose for the Company's planned future trials has been selected to be 50 mg TID....A separate study evaluated an alternative dose of neflamapimod, 80 mg BID, which met its primary objectives for safety, tolerability, and pharmacokinetics. The regimen was well tolerated, with no new safety signals identified over 24 weeks in 26 participants with DLB and achieved target trough plasma concentrations predicted to optimize p38α inhibition..."

P2 data • PK/PD data • Dementia • Lewy Body Disease

Neflamapimod Demonstrated Durable Slowing of Basal Forebrain Atrophy (CervoMed Press Release) - "Over the 16 weeks of the placebo-controlled period of the RewinD-LB trial, neflamapimod-treated participants demonstrated increased right basal forebrain (BF) volume relative to placebo, as measured by structural and functional MRI. BF atrophy is the primary pathogenic driver of disease expression and progression in DLB. Right basal forebrain volume remained stable over 48 weeks (placebo-controlled phase + extension) in participants receiving neflamapimod in both phases and stabilized after treatment initiation in the extension in prior placebo recipients....Increases in functional connectivity between the right BF and the right default mode network (DMN) were also observed during the neflamapimod-only extension. Disruption in BF-DMN connectivity, marked by abnormal activity in these regions, has been linked to neurodegenerative disorders such as DLB."

P2b data • Dementia • Lewy Body Disease

Analyses Reinforce Observed Treatment Effect of Neflamapimod in “Pure” DLB and Support Planned Phase 3 Dose (CervoMed Press Release) - "Exploratory analyses of the placebo-controlled phase of RewinD-LB identified treatment effects favoring neflamapimod on CDR-SB, with a consistently improving treatment effect at progressively lower plasma pTau181 levels. The plasma pTau181 cut-off of <21 pg/mL has recently been identified in scientific literature as the optimal cut-off to exclude AD pathology. Further, the improvement relative to placebo observed in the subset of participants with pTau181 <21 pg/mL was limited to those patients who were above the median trough plasma drug concentration for the study as a whole...These effects were also demonstrated by the extension-phase results, where a batch of capsules (DP Batch B) achieved higher plasma drug concentrations than the batch used during the placebo-controlled phase (DP Batch A). A within-participant comparison of DP Batch B demonstrated a significant improvement in change in CDR-SB compared to placebo..."

New P3 trial • P2b data • Dementia • Lewy Body Disease

CervoMed Inc…announced today that it has completed enrollment in its Phase 2a study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia (Investing.com) - "The trial enrolled 25 participants who will take oral neflamapimod at doses of either 40 milligrams three times daily or 80 milligrams twice daily for 24 weeks, followed by a 12-week randomized, double-blind placebo-controlled extension. The study is being conducted at academic centers in the United States...The company said it expects to share first clinical data in the first quarter of 2027."

Enrollment closed • P2a data • Dementia

RESTORE: A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: EIP Pharma Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Oct 2026 | Trial primary completion date: May 2026 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: EIP Pharma Inc | Recruiting ➔ Active, not recruiting

Enrollment closed

Plasma Drug Exposure-response Relationship Of Neflamapimod In The Rewind-LB Trial In Patients With Dementia With Lewy Bodies (AAIC 2026) - No abstract available

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

The P38alpha Kinase Inhibitor Neflamapimod Has A Beneficial Effect On Basal Forebrain Atrophy Assessed By MRI In Dementia With Lewy Bodies (AAIC 2026) - No abstract available

Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • MAPK14

The Oral P38a Kinase Inhibitor Neflamapimod Slows The Rate Of Clinical Worsening In Dementia With Lewy Bodies (DLB) (AAIC 2026) - No abstract available

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

Results Of A Phase 2 Study Of Neflamapimod 80mg Twice-daily In Dementia With Lewy Bodies (AAIC 2026) - No abstract available

P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

CervoMed Secures New U.S. Patent Protecting Use of Neflamapimod in Pure Dementia with Lewy Body Patients into 2042 (The Manila Times) - "The patent is designed to protect the Company’s strategy targeting the treatment of patients with pure DLB. Currently, there are no approved treatments for DLB in the United States or European Union."

Patent • Dementia • Lewy Body Disease

CervoMed Announces Private Placement Financing and Plan to Focus on Strategic Partnering to Advance Neflamapimod into Phase 3 for Dementia with Lewy Bodies (The Manila Times) - "...Company anticipates upfront gross proceeds of approximately $10.5 million, before deducting offering-related fees and expenses...The net proceeds from the financing will extend the Company’s anticipated cash runway into the second quarter of 2027 and will support the pursuit of a strategic partnership to advance neflamapimod into Phase 3 development for the treatment of dementia with Lewy bodies (DLB)...Anticipated initiation of Phase 2a clinical trial of neflamapimod in ALS through the funded EXPERTS-ALS platform provides a capital-efficient opportunity to further expand into rare neurological disease space; Neflamapimod 50mg TID dose recently selected for EXPERTS-ALS Phase 2a clinical trial; On track for submission to regulatory authorities in the UK, with first patient dosed anticipated in the fourth quarter of 2026."

Financing • MHRA filing • New P2a trial • New P3 trial • Dementia • Lewy Body Disease

CervoMed’s anticipated milestones for the remainder of 2026, subject to available funding, include (Yahoo Finance) - "DLB: CervoMed [has initiated clinical site startup activities in the U.S. utilizing internal resources and] plans to initiate a Phase 3 trial evaluating neflamapimod in patients with DLB in the second half of 2026...ALS: CervoMed expects EXPERTS-ALS to dose the first patient with ALS with neflamapimod by the end of 2026."

New P2a trial • New P3 trial • Amyotrophic Lateral Sclerosis • Dementia • Lewy Body Disease

Butyrate Regulates the Blood-Brain Barrier Transport and Intraendothelial Accumulation of Alzheimer's Disease Amyloid-Beta Peptides. (PubMed, Mol Pharm) - "The roles of insulin signaling nodes, including AKT, ERK, mTOR, and p38 phosphorylation, were investigated by using specific inhibitors MK2206, Trametinib, Rapamycin, and VX-745, respectively. These changes may also enhance BBB integrity by increasing claudin-5 expression, stabilizing the extracellular matrix, and upregulating TIMP-2. Collectively, this study highlights butyrate as a potential therapeutic modulator of AD-associated BBB dysfunction."

Journal • Alzheimer's Disease • CNS Disorders • Aβ42 • CLDN5 • TIMP2

Nanotechnology-based encapsulation of neflamapimod: A new therapeutic strategy for lewy body dementia. (PubMed, Colloids Surf B Biointerfaces) - "Most importantly, INV-NEFLA ameliorated mitochondrial dysfunction in DLB patient-derived lymphoblasts by upregulating both oxygen consumption rates and glycolytic reserves. Consequently, INV-mediated nanoencapsulation emerges as a potent delivery system for NEFLA, potentially optimizing therapeutic outcomes in DLB through enhanced efficacy and versatile delivery pathway."

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

Preliminary Evidence that Neflamapimod has a Beneficial Effect on Basal Forebrain Atrophy Assessed by MRI in Dementia with Lewy Bodies (AAN 2026) - "At week 48, change from baseline in right NbM volume was +1.9 mm³ (95% CI –5.5 to +9.3), associated with improved right BF–default mode network static functional connectivity (p = 0.019 for increase from baseline). Conclusions These findings provide preliminary evidence that neflamapimod may reduce basal forebrain atrophy in DLB and support MRI as a tool to assess treatment effects on cholinergic degeneration."

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