CervoMed Inc (CRVO) News & EventsCRVOCervoMed Inc

CervoMed Publishes Neflamapimod Clinical Trial Results

CervoMed announced that results from the placebo-controlled phase of the Phase 2b RewinD-LB clinical trial of neflamapimod in dementia with Lewy bodies, or DLB, have been published in Alzheimer's Research & Therapy. The paper follows another recent publication in Cells reporting data that demonstrated neflamapimod's inhibition of interleukin-1 beta signaling and modulation of neuroinflammatory processes implicated in cognitive decline in DLB. Neflamapimod did not confirm the results of CervoMed's Phase 2a AscenD-LB clinical trial with respect to the primary outcome measure in the full intention-to-treat population. In an MRI substudy, neflamapimod demonstrated a statistically significant increase in right basal forebrain volume compared with placebo. Neflamapimod showed greater benefit versus placebo in patients without Alzheimer's disease co-pathology. Patients with drug blood levels above the study median showed treatment effects comparable to those seen in Phase 2a; patients below the median did not. Neflamapimod was well tolerated, with the incidence of discontinuation due to adverse events being 2.5% with neflamapimod and 1.3% with placebo. "These publications demonstrate beneficial effects of neflamapimod on clinical endpoints and biomarkers of the underlying disease process that follow a consistent plasma drug-response relationship, with activity most evident at trough plasma concentrations of approximately 4 ng/mL or higher. We believe the alignment of clinical, biomarker, and imaging findings supports further development, particularly in patients without Alzheimer's disease co-pathology, and reinforces the rationale for a 100 mg twice-daily dose using the new tablet formulation. This regimen is projected to achieve target trough concentrations in more than 90% of participants, providing more consistent drug exposure within the range associated with clinical activity in our prior clinical trials without substantially increasing peak concentrations or overall exposure," said John Alam, founder and CEO of CervoMed.

CervoMed Reports Initial Data Showing Reduction in NfL Levels

CervoMed announced initial data showing a reduction in mean plasma levels of neurofilament light chain, or NfL, a key biomarker of neuronal damage and degeneration, over the first 12 weeks of treatment with neflamapimod in the open-label portion of the company's Phase 2a clinical trial in nonfluent variant primary progressive aphasia, or nfvPPA. The findings were presented in a late-breaking oral presentation at the 15th International Society of Frontotemporal Dementias, or ISFTD, annual meeting in Philadelphia, Pennsylvania. The presentation included initial results for two plasma biomarkers, NfL and glial fibrillary acidic protein, or GFAP, during the first 12 weeks of an open-label treatment period with neflamapimod, finding: At baseline, relative to the general population, 18 of 25 participants had elevated NfL levels and four of 25 had elevated GFAP levels. Mean baseline NfL across all participants was 45.7 pg/mL, and mean baseline GFAP was 103.4 pg/mL. Over the first 12 weeks, mean change in plasma NfL levels was ~ 3.1 pg/mL, with most of the decline occurring between weeks six and 12. In an exploratory analysis of participants with baseline NfL levels at or above the median, mean change in NfL levels was ~ 5.7 pg/mL over 12 weeks. GFAP levels were stable over the first 12 weeks. Neflamapimod was generally well tolerated, and no new safety signals were identified. One patient with elevated liver enzyme levels met protocol-defined criteria for discontinuation. The patient was asymptomatic, with no associated bilirubin elevation, and the elevation resolved with treatment discontinuation. The Phase 2a clinical trial of neflamapimod for the treatment of nfvPPA was designed to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in participants with nfvPPA. The 36-week trial enrolled 25 participants and is being conducted at academic medical centers in the United States and United Kingdom. The study includes 24 weeks of open-label treatment with neflamapimod 40 mg three times daily or 80 mg twice daily, followed by a 12-week double-blind, placebo-controlled randomized withdrawal period in which participants are assigned 1:1 to continue neflamapimod or switch to placebo.

CervoMed Introduces New 50 mg Tablet to Support Clinical Trials

CervoMed announced pharmacokinetic, PK, regulatory, and manufacturing advances that enable a higher-dose, twice-daily oral regimen of neflamapimod in future clinical trials. The developments include a new neflamapimod 50 mg oral tablet formulation with a PK profile favorable for twice-daily dosing, the U.S. Food and Drug Administration's removal of the previous plasma drug exposure limit, and the implementation of a controlled manufacturing process designed to support reproducible, large-scale tablet production. "The new 50 mg tablet addresses the formulation issue identified during the Phase 2b RewinD-LB study and we intend to move forward with it in future clinical development," said John J. Alam, M.D., Chief Executive Officer of CervoMed. "Combined with the FDA's removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials, while reducing dosing frequency from three times to twice daily."