- ServoMed Inc. (CRVO) is a clinical-stage company focused on developing **Neflumab**, an investigational orally administered small molecule brain penetrant, for neurological diseases.  **[0001053691_2195995_0]** **[0001053691_2195995_1]** 
- Neflumab's lead indication is **Dementia with Lewy Bodies (DLB)**, a chronic neurodegenerative disease that currently has **no approved therapies** and represents a large market opportunity, with an estimated **150,000-280,000 patients in the US**.  **[0001053691_2195995_1]** **[0001053691_2195995_2]** 
- Phase 2b clinical data for Neflumab in pure DLB patients demonstrated a **52% reduction** in the mean change in CDR Sum of Boxes (CDR SB), which increased to **82%** in the enriched population, and showed a **67-75% reduced risk of disease progression**.  **[0001053691_2195995_3]** **[0001053691_2195995_4]** 
- The company is preparing to initiate a **24-week, 300-patient Phase 3 trial** for Neflumab in pure DLB in **2026**, following ongoing discussions with the FDA regarding the trial design.  **[0001053691_2195995_4]** **[0001053691_2195995_5]** **[0001053691_2195995_6]** 
- Neflumab has exhibited a **favorable safety profile** across all studies to date, with no discontinuations due to severe adverse events.  **[0001053691_2195995_4]**

ServoMed Inc. Provides Update on Neflumab for Dementia with Lewy Bodies

- CervoMed Inc. (CRVO) is a clinical-stage company focused on neurological diseases, with its lead product, **neflamapimod**, preparing to enter **Phase 3 trials for dementia with Lewy bodies (DLB)**.  **[0001053691_2195964_1]** 
- **Phase 2 clinical data** for neflamapimod demonstrated significant improvements in DLB patients, including a **52% to 82% reduction in the mean change in CDR-Sum of Boxes (CDR-SB) scale** and a **67% to 75% reduced risk of progression** in pure DLB patients with the effective drug formulation.  **[0001053691_2195964_2]** **[0001053691_2195964_3]** **[0001053691_2195964_4]** 
- The company plans to initiate its **Phase 3 pivotal studies in Q3 2026**, which will be a 24-week placebo-controlled randomized study involving approximately **300 pure DLB patients**.  **[0001053691_2195964_4]** **[0001053691_2195964_5]** 
- DLB represents a **large, untapped market opportunity** with **no currently approved therapies**, and neflamapimod has received **Fast-Track designation** from the FDA.  **[0001053691_2195964_1]** **[0001053691_2195964_2]** **[0001053691_2195964_5]** 
- Beyond DLB, CervoMed's pipeline also includes neflamapimod in **Phase 2 trials for recovery after stroke** and **frontotemporal dementia** (the latter having orphan drug designation).  **[0001053691_2195964_5]**

CervoMed provides update on neflamapimod Phase 3 plans for Dementia with Lewy Bodies

- CervoMed Inc. (CRVO) is a clinical-stage company focused on neurological diseases of aging, with its lead product, **neflamapimod**, targeting **Dementia with Lewy Bodies (DLB)**.  **[0001053691_2196849_0]** **[0001053691_2196849_1]** 
- The company is preparing to initiate **Phase 3 pivotal studies** for neflamapimod in pure DLB, with discussions ongoing with the FDA regarding trial design, including a 24-week placebo-controlled study with approximately **300 patients**, aiming for a **Q3 2026 start**.  **[0001053691_2196849_1]** **[0001053691_2196849_4]** **[0001053691_2196849_5]** **[0001053691_2196849_6]** 
- Phase 2 clinical data demonstrated significant improvement in the CDR-Sum of Boxes scale, showing a **52% reduction** in the mean change for all participants on the effective drug batch, increasing to an **82% reduction** in the enriched pure DLB population, and a **67%-75% reduction** in the risk of disease progression.  **[0001053691_2196849_2]** **[0001053691_2196849_3]** **[0001053691_2196849_4]** 
- DLB represents a **large, untapped market opportunity** with no currently approved therapies, and neflamapimod has a favorable safety profile across all studies to date.  **[0001053691_2196849_1]** **[0001053691_2196849_2]** **[0001053691_2196849_4]**

CervoMed Inc. Prepares for Phase 3 Trial of Neflamapimod in DLB

- CervoMed Inc. is a clinical-stage company focused on neurological diseases of aging, with its lead product, **neflamapimod**, preparing to enter Phase 3 trials for **dementia with Lewy bodies (DLB)**.  **[0001053691_2196834_1]** 
- The company has reported **positive Phase 2 clinical data** for neflamapimod in pure DLB patients, demonstrating significant improvements in the CDR-Sum of Boxes scale and a **67% to 75% reduction in the risk of disease progression** for patients on the active drug (Batch B) compared to placebo.  **[0001053691_2196834_3]** **[0001053691_2196834_4]** 
- DLB represents a **large and untapped commercial market** with no currently approved therapies, affecting an estimated **150,000 to 180,000 patients in the US**.  **[0001053691_2196834_1]** **[0001053691_2196834_2]** 
- CervoMed is in discussions with the FDA regarding the design of its Phase 3 trial, which is expected to be a **24-week placebo-controlled randomized study** involving approximately **300 patients** and is anticipated to start in **Q3 2026**.  **[0001053691_2196834_4]** **[0001053691_2196834_5]** **[0001053691_2196834_6]** 
- Beyond DLB, CervoMed also has neflamapimod in Phase 2 clinical trials for **recovery after stroke** and **frontotemporal dementia** (primary progressive aphasia).  **[0001053691_2196834_5]**

CervoMed Provides Update on Neflamapimod Development for Dementia with Lewy Bodies

- CervoMed Inc. announced new data from its Phase 2b RewinD-LB trial, demonstrating neflamapimod's potential as a treatment for **dementia with Lewy bodies (DLB)**.  **[1053691_0001437749-25-030719_ex_867784.htm:0]** 
- The data showed **significant improvement** in the primary outcome measure, Clinical Dementia Rating Sum of Boxes (CDR-SB), in participants with a low likelihood of Alzheimer's disease co-pathology.  **[1053691_0001437749-25-030719_ex_867784.htm:0]** 
- Neflamapimod also led to a **significant reduction in plasma glial fibrillary acidic protein (GFAP)**, a neurodegeneration biomarker, which correlated with improved CDR-SB scores.  **[1053691_0001437749-25-030719_ex_867784.htm:0]** **[1053691_0001437749-25-030719_ex_867784.htm:2]** 
- The company anticipates **U.S. Food and Drug Administration (FDA) feedback on its Phase 3 trial design** in the **fourth quarter of 2025**.  **[1053691_0001437749-25-030719_ex_867784.htm:0]**

CervoMed (CRVO)