CervoMed’s Neflamapimod Joins UK EXPERTS-ALS Trial with 35-80 Patient Cohorts
CervoMed’s oral p38 inhibitor neflamapimod was selected for the UK EXPERTS-ALS platform to assess its effect on neurofilament light chain in 35 ALS patients over 18–24 weeks with expansion to 80 participants; first dosing expected late 2026. Trial costs are funded by NIHR and motor neuron disease charities.
1. Inclusion in EXPERTS-ALS Platform
CervoMed’s neflamapimod has been elected for the EXPERTS-ALS platform, marking the first evaluation of this oral p38 inhibitor in amyotrophic lateral sclerosis. The trial is set to initiate first dosing by late 2026 under a randomized, multicenter, open-label design.
2. Trial Design and Endpoints
Approximately 35 participants will receive neflamapimod over an 18–24 week period, with potential expansion to 80 patients based on interim biomarker findings. The primary endpoint is reduction in blood neurofilament light chain levels, while secondary and exploratory endpoints include clinical and survival measures.
3. Funding and Partnerships
The trial is funded by the UK National Institute for Health and Care Research and major motor neuron disease charities, with sponsorship from Sheffield Teaching Hospitals NHS Foundation Trust. Additional support will extend the study duration and underwrite related laboratory research.
4. Neflamapimod’s Clinical Rationale
Neflamapimod selectively inhibits p38 alpha MAP kinase, a driver of neuroinflammation and synaptic dysfunction, and crosses the blood–brain barrier. Prior Phase 1 and 2 trials in dementia with Lewy bodies demonstrated favorable safety, target engagement and biomarker effects, underpinning its selection for ALS evaluation.