Announcement • Jul 09
CervoMed Completes Enrollment In Phase 2a Study Of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia
CervoMed Inc. has completed enrollment in the Phase 2a study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia (FTD). Interim biomarker data from the study will be presented at the 19th Clinical Trials on Alzheimer's Disease (CTAD) Conference in Boston, Massachusetts, taking place November 16–19, 2026. The Phase 2a study was designed to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in participants with nfvPPA. The trial enrolled 25 participants, taking oral neflamapimod (40 milligram TID [n = 19] or 80 milligram BID [n = 6]) for 24 weeks, followed by a 12-week, randomized, double-blind placebo-controlled extension. The study is being conducted at academic centers in the U.S. A recent preclinical study published in Nature Neuroscience demonstrated that axonal transport dysfunction occurs in the early stages of genetic forms of FTD where the primary mutation is in the microtubule-associated protein tau, leading to the abnormal build-up of misfolded tau proteins in the brain that is the pathologic driver in approximately half of patients with FTD. After establishing that p38a inhibition reduced axonal transport deficits in transgenic mice harboring tau mutations associated with human disease (FTD-Tau), the authors used neflamapimod, a known pharmacological inhibitor of p38a, to test whether it could reproduce the effect. Imaging the mice before and after treatment, they found that sustained inhibition improved axonal transport and reversed the underlying deficits. Interim results from the Phase 2a clinical trial will be presented at CTAD. Title: Phase 2a clinical trial of the oral p38a kinase inhibitor neflamapimod in patients with non-fluent variant primary progressive aphasia. Poster Session: Clinical Trials – Phase I & IIA. Poster ID: P441. Presenter: Ian M. Grant. Co-Authors: Hugo Botha, Lawerance S. Honig, Douglas W. Scharre, Amanda Gardner, Kelly Blackburn, Bradley F. Boeve, John J. Alam, David J. Irwin. Affiliation: Northwestern Feinberg School of Medicine, Mayo Clinic, Columbia University Irving School of Medicine, The Ohio State University Wexner School of Medicine, CervoMed, University of Pennsylvania Perelman School of Medicine. Date/Time: Monday, November 16 (2:00 p.m. ET) – Tuesday, November 17 (5:30 p.m. ET). NfvPPA, a type of FTD, gradually causes people with the condition to have trouble expressing themselves, although they still understand the meaning of words. Initially, they might use shorter phrases or pause while speaking and have difficulty pronouncing words. It can also be challenging for them to understand long or complex sentences. In advanced nfvPPA, people may stop speaking completely, and difficulty with planning and judgment, as well as moving, can also occur. There are an estimated 10,000–15,000 people living with nfvPPA in the U.S. and 15,000–20,000 in the E.U. Currently there are no approved treatments for nfvPPA in the U.S. or E.U. Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of frontotemporal disorders, from which interim biomarker data is anticipated in the early fourth quarter of 2026, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026.
